Regulatory

Regulatory

EPM Scientific:

Specialist Talent Partner in Regulatory Affairs Recruitment for Life Sciences

Constant change is a hallmark of the life sciences industry. 2023 alone saw significant regulatory changes, such as the May lapse of the Federal Public Health Emergency (PHE) for the Covid-19 pandemic. This ended regulatory changes that benefited providers during the pandemic. From increased scrutiny of data integrity to a changing political landscape, Regulatory teams keep companies up to date with change. By managing Regulatory enforcement actions and maintaining compliance with changing local requirements, they help take products through to market. Let EPM Scientific find and deliver Regulatory talent to provide advice around biological products, drugs, human cell and tissue products, medical devices, and more.

How we can help

Your life sciences company can take advantage of over 10 years of experience in sourcing sought-after Regulatory talent. We invest in the ongoing growth, development of our talent specialists, in best-in-class technologies, and our extensive professional network of candidates to assure our clients of consistent quality service and find teams and individuals for Regulatory roles.

Regulatory talent solutions

Turn to EPM Scientific for your Regulatory talent needs, whether your company needs contract, permanent, or multi-hire solutions. Thanks to our global talent hubs, we will find proven and promising professionals and place them with speed and efficiency. We find and deliver interim managers and contractors for long-term and time-sensitive functions via our vast network of candidates, and we offer additional benefits through bespoke retained and contingent services.

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Benefits of working with us

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Experience

We have over a decade’s worth of experience as a leading talent partner in Life Sciences & Pharma.

Network

A vast, global network of the best, in-demand professionals, working with the world’s largest Life Sciences institutions, to take drugs, devices and therapeutic applications through from conception to completion.

Knowledge

Our award-winning talent specialists offer bespoke, tailored guidance on the latest hiring trends and industry news to help you achieve your goals.

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Looking to hire?

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Regulatory Jobs

EPM Scientific can find your next Regulatory career opportunity in life sciences. We hire for roles including Director of Regulatory Affairs, Head of Quality Assurance and Regulatory Affairs, Senior Director Regulatory CMC, and Senior Clinical Regulatory Manager.

Director Regulatory Affairs

Title: Director Regulatory Affairs A small sized diagnostics company is seeking a Director of Regulatory Affairs to lead the regulatory submissions, strategy, and maintenance activities for their existing products and new products in development. They are pioneering the field with innovative machine learning-based liquid biopsy mRNA expression tests, designed for both standard-of-care and pharmaceutical trials. These products are patented and unique to the cancer diagnostics market. This role reports directly into the CEO/CSO. Responsibilities: Register two prospective studies with the FDA Serve as the point of contact for submissions to all notified bodies Manage all communications, meeting scheduling, meeting materials and meeting minutes with the FDA and other agencies including requests for meetings, advice, etc. Draft and formulate pre-sub and submission packages/dossiers, which include technical documents and data, e.g. assay validation protocols and reports, clinical reports/data and/or other development documentation. Develop, draft and author regulatory submission documentation, including traditional 510K, de-novo 510K, SRDs, IDEs, and PMAs. Develop regulatory strategies alongside the CSO Act as the lead Regulatory personnel represent Qualifications: 6+ years of experience in IVD Regulatory Affairs Preferred experienced with LDTs Ideally experienced with oncology molecular tests, e.g. NGS, multiplex PCR, etc. Successfully authored and files 510k, de-novo 510/PMA, BTD submissions Hands on experience coordinating FDA procedures: planning FDA meetings, leading FDA meetings, taking notes for FDA meetings, etc. International IVD experience Robust understanding of LDT under CLIA/CAP, NYSDOH, and the FDA LDT Final Rule released May 2024.

US$160000 - US$200000 per annum
Connecticut
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Vice President Regulatory Affairs

Title: Vice President Regulatory Affairs An exciting pharmaceutical company is seeking a VP Regulatory Affairs to join the team in making on a meaningful impact on the lives of patients through innovative healthcare solutions. This mid-sized company currently has multiple already approved products with a strong pipeline on the way. This is an opportunity to have a hands on role in guiding the regulatory strategy for cutting edge therapies in the rare disease space. Responsibilities: Collaborate with cross-functional teams, including clinical, commercial, and medical affairs, to develop and implement global regulatory affairs strategies across a product portfolio. Oversee the development and continuous refinement of regulatory policies, procedures, and standard operating procedures (SOPs). Partner with commercial, clinical development, and medical affairs teams to design and implement launch strategies, tactics, and lifecycle management plans. Conduct regulatory assessments to identify product opportunities, risks, and potential challenges. Provide regulatory expertise in the development and approval of promotional materials and marketing campaigns. Work closely with legal, commercial, and clinical teams to develop and review product labeling, advertising, and promotional materials to ensure compliance with regulations. Lead, mentor, and manage the regulatory affairs team, fostering a culture of compliance and high performance. Develop and enhance organizational policies and procedures for regulatory affairs and compliance. Anticipate global regulatory changes and proactively adapt strategies to address them. Provide strategic guidance on all aspects of regulatory requirements in drug development. Interpret communications and decisions from regulatory bodies such as the FDA and international health authorities, developing strategies to resolve issues effectively. Draft, review, and submit responses and documentation to regulatory agencies, ensuring compliance with submission requirements. Communicate with regulatory agencies regarding submission strategies, regulatory pathways, and follow-up actions. Design innovative regulatory strategies for label enhancements and lifecycle product management. Advise senior management on the status of global regulatory strategies, tactics, and risk assessments related to regulatory filings. Review and approve external communications, advertising, and promotional labeling to ensure compliance with corporate policies and applicable laws. Oversee project planning, ensuring priorities are set and key milestones are met in a timely manner. Manage collaborations with contract research organizations (CROs) or external partners, ensuring global submissions align with regulatory requirements. Maintain up-to-date knowledge of the global regulatory landscape, competitive trends, and regulatory guidelines. Establish and direct global benefit-risk strategies for products at all stages of development, including pre-market, post-market, and lifecycle management. Perform other duties as necessary, depending on organizational needs. Qualifications Bachelor's degree in a scientific discipline (advanced degree such as Ph.D. or PharmD preferred) 15+ years of experience in Regulatory Affairs within the pharmaceutical or biotech industries Must have experience in the rare disease space Demonstrated ability to design and implement regulatory strategies for innovative products. In-depth understanding of FDA regulations, ICH guidelines, and the drug development process. Experience preparing regulatory submissions, including INDs and clinical trial documents. Prior experience with clinical trials and regulatory documentation is required. Experience with inhalation products, biologics, or related areas is preferred. Comfortable working in a fast-paced, high-visibility environment with evolving priorities. Willingness to travel up to 15%

US$290000 - US$365000 per annum
Boston
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Director Regulatory Affairs

Director of Regulatory Affairs Strategy This position is with a rapidly growing pharmaceutical company known for its commitment to advancing transformative therapies. In this role you will have a unique opportunity to lead regulatory strategies for innovative pharmaceutical products, making a meaningful impact on patient health. You'll collaborate with cross-functional teams and engage directly with regulatory agencies, influencing critical decisions in drug development. Key Responsibilities: Oversee daily regulatory activities for projects involving compounds in development or on the market, including submission strategies and regulatory intelligence. Collaborate with Project Teams to develop regulatory and product strategies, including drafting labeling and NDA package inserts. Work with various departments to formulate and execute effective Regulatory Strategies, assessing and communicating regulatory risks and opportunities. Manage submissions and maintenance of INDs, NDAs, MAAs, and related documents. Support due diligence activities for potential product acquisitions or partnerships. Serve as the primary regulatory contact with agencies, including the FDA, and represent the regulatory function in key meetings. Monitor the regulatory landscape and communicate updates to stakeholders. Advise on regulatory requirements to support business strategies, providing expert guidance on scientific and medical issues. Qualifications: Bachelor's degree in life sciences or related field; advanced degree preferred. Minimum 10 years of experience in pharmaceutical regulatory drug development. Proven track record in new chemical entity and line extension filings. Experience interacting with global health authorities and conducting due diligence. Strong knowledge of global pharmaceutical regulations and excellent communication skills.

Up to US$225000 per annum
Philadelphia
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Senior Regulatory Affairs Quality Systems Specialist

Title: Senior Regulatory Affairs and Quality Systems Specialist The Regulatory Affairs and Quality Systems Specialist is responsible for supporting regulatory and quality assurance processes related to in vitro diagnostic (IVD) medical devices. This organization offers a dynamic and collaborative work environment where you have the opportunity to make a meaningful impact in the field of medical diagnostics. With a focus on innovation and excellence, this company provides ample opportunities for professional growth and development, supporting career advancement through hands-on experience and cross-functional collaboration. You will be empowered to contribute to projects that improve healthcare outcomes globally, particularly in the realm of in vitro diagnostic devices. Key Responsibilities Project Compliance and Oversight: Attend project meetings to ensure all medical device design, development, and manufacturing activities meet regulatory requirements, including U.S. FDA's QSR (21 CFR Part 820), ISO 13485, and other relevant standards. Regulatory Strategy Support: Collaborate with internal teams and external partners to develop and implement a global regulatory strategy to meet U.S. FDA requirements and support business goals. Quality System Management: Assist in the management of the organization's Quality System in relation to bringing medical device products to market, including document control and regulatory compliance. Regulatory Submissions: Provide guidance and support in the drafting and submission of regulatory filings, with a particular focus on FDA Q-Submissions and premarket notifications. Clinical and Validation Support: Assist in the preparation and review of technical documents, protocols, and data for clinical trials, validation, verification, and product manufacturing. Regulatory Documentation Management: Maintain regulatory files and databases to ensure accuracy and continuity of information across various platforms. Process Improvement and SOPs: Draft and update Standard Operating Procedures (SOPs) to ensure they reflect current regulatory practices and requirements. Post-market Activities: Manage adverse event reporting, medical device recalls, and product corrections/removals. Product Labeling Oversight: Ensure that product labeling, including Instructions for Use (IFU), complies with all applicable regulatory requirements. Risk Management and Lifecycle Support: Contribute to risk management activities and assist in monitoring product lifecycle changes. Third-Party Audits: Participate in internal and supplier audits, ensuring compliance with regulatory standards and quality system requirements. Qualifications Language Skills: Fluency in English (written and verbal) and Korean (written and verbal) is a Must Bachelor's degree in Engineering, Biology, Biochemistry, Microbiology, or a related field. 5-6 years of experience in a regulated industry, particularly in medical device quality assurance, regulatory affairs, or quality systems management. Experience with FDA and ISO 13485 regulations, including knowledge of IVD medical device regulations, risk management, and design controls. Regulatory Expertise: In-depth knowledge of FDA QSR (21 CFR Part 820), ISO 13485, and other relevant standards for medical device manufacturing. Problem Solving and Adaptability: Ability to adjust strategies and plans as business needs evolve. Stakeholder Communication: Strong interpersonal and communication skills to influence and align stakeholders across the organization. Leadership and Organization: Demonstrated leadership ability and project management skills in fast-paced environments. Technical Writing: Ability to draft and review complex technical documentation, regulatory submissions, and SOPs. Attention to Detail: High level of accuracy in data management and documentation. Time Management: Ability to prioritize multiple projects and meet deadlines in a dynamic environment. Public Speaking and Training: Experience speaking in large group settings and training teams on regulatory and quality requirements. Software Skills: Proficiency with MS Office (Word, Excel, PowerPoint, Outlook) is required. Travel Requirements: Must be willing to travel to US and international based offices

US$90000 - US$120000 per annum
Cincinnati
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Associate Director Regulatory Affairs

Title: Associate Director Regulatory Affairs A small but growing clinical stage company is seeking an Associate Director Regulatory Affairs to join the team in a remote capacity. They are seeking a well-rounded RA professional to lead the Regulatory Strategy for their pipeline of phase III products in the rare disease space. Responsibilites: Serves as regulatory affairs representative to provide input on global clinical trials, including coordination of health authority requests, filing activities, and ensuring that documentation and reporting systems are maintained and compliant. Ensures the US regulatory strategy is aligned with the global strategy for assigned programs, including for investigational new drug application submissions. Contributes to the strategy for US FDA interactions with the cross-functional team, including development of content, format, and accountability for regulatory submissions and related supplements and amendments, such as FDA meeting requests, briefing books, meeting minutes, orphan drug annual reports, and DSURs. Supports maintenance and organization of regulatory documentation in partnership with regulatory operations and other teams. Supports US labeling development for NDA. Delivers regulatory achievements for assigned project(s), including the assessment of risks with mitigation strategies, emerging data, and the probability of regulatory success. Develops collaborative and effective relationships across key internal and external partners (e.g., regulatory CMC, regulatory operations, CROs/vendors) to enable rapid and effective submissions, approvals, and other product maintenance activities including clinical trial support and documents in support of global regulatory submissions, health authority meetings and requests, and securing approvals. Leads cross-functional teams, in partnership with global regulatory lead, to develop and execute regulatory strategies for assigned projects and programs. Requirements/Key Attributes: Master's or above degree in Pharmacy, Chemistry, Biochemistry, Biology, Biotechnology, or comparable preferred; bachelor's degree in a scientific field required. 8+ years' experience in drug development, 5+ years in regulatory affairs, rare disease experience preferred. Experience as direct contact with Major Health Authority desired. Previous experience in developing materials, attending, and supporting team preparation for Major Health Authority interactions. Strong experience with CTD format and content of regulatory filings for INDs, NDA/BLAs, MAAs, including developing strategy, writing, and reviewing documents. Strong organizational skills, ability to multi-task and manage workload independently. Detailed knowledge of regulatory drug development including product approval and maintenance. Ability to think strategically and critically evaluate risks to regulatory activities. Ability to work strategically within a business-critical and high-profile development program. Excellent verbal and written communication and presentation skills (English). Strong team player and ability to work across functions (matrix regulatory team). Comfortable in a small company environment that is fast-paced, challenging, and where all leaders must take a hands-on approach to get results. Excited and driven by science and the vision to improve disease management and patient care.

US$160000 - US$190000 per annum
Boston
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Regulatory Affairs Manager

Title: Regulatory Affairs Manager Summary: A development-stage biopharmaceutical company, dedicated to improving patient access to essential therapies and developing innovative treatments for serious diseases is looking to bring on a Manager of Regulatory Affairs to join their team! This company is growing rapidly and they are looking for someone to provide their expertise in generic drugs, ANDA submissions, and regulatory affairs CMC based out of their office in the greater Miami area. This role will give you a great opportunity to contribute to the company's mission to develop treatment options for diseases where therapeutic options are inadequate. The Manager will be responsible for… Formulating and executing regulatory strategies for the development of generic products, product modifications, and life cycle management Actively engaging in the preparation, submission, and management of regulatory filings, with a primary focus on ANDA submissions to the FDA Contributing to and supervise the preparation of dossiers with external vendors, ensuring compliance with regulatory standards and guidelines Collaborating with cross-functional teams to compile and review submission materials Working closely with Pharmaceutical Development, Clinical Development, Quality Assurance, and other departments to ensure regulatory requirements are incorporated into product development and life cycle processes The Manager should have the following qualifications: Bachelor's degree in a scientific discipline; advanced degree (MS, PhD) preferred 4+ years of Regulatory Affairs experience in pharmaceutical industry Vast experience with regulatory submissions, especially ANDA submissions Strong interpersonal, leadership, and communication skills Thrives in fast-paced, hands-on environments

Negotiable
Florida
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Vice President Regulatory Affairs

Title: Vice President Regulatory Affairs An exciting pharmaceutical company is seeking a VP Regulatory Affairs to join the team in making on a meaningful impact on the lives of patients through innovative healthcare solutions. This mid-sized company currently has multiple already approved products with a strong pipeline on the way. This is an opportunity to have a hands on role in guiding the regulatory strategy for cutting edge therapies in the rare disease space. Responsibilities: Collaborate with cross-functional teams, including clinical, commercial, and medical affairs, to develop and implement global regulatory affairs strategies across a product portfolio. Oversee the development and continuous refinement of regulatory policies, procedures, and standard operating procedures (SOPs). Partner with commercial, clinical development, and medical affairs teams to design and implement launch strategies, tactics, and lifecycle management plans. Conduct regulatory assessments to identify product opportunities, risks, and potential challenges. Provide regulatory expertise in the development and approval of promotional materials and marketing campaigns. Work closely with legal, commercial, and clinical teams to develop and review product labeling, advertising, and promotional materials to ensure compliance with regulations. Lead, mentor, and manage the regulatory affairs team, fostering a culture of compliance and high performance. Develop and enhance organizational policies and procedures for regulatory affairs and compliance. Anticipate global regulatory changes and proactively adapt strategies to address them. Provide strategic guidance on all aspects of regulatory requirements in drug development. Interpret communications and decisions from regulatory bodies such as the FDA and international health authorities, developing strategies to resolve issues effectively. Draft, review, and submit responses and documentation to regulatory agencies, ensuring compliance with submission requirements. Communicate with regulatory agencies regarding submission strategies, regulatory pathways, and follow-up actions. Design innovative regulatory strategies for label enhancements and lifecycle product management. Advise senior management on the status of global regulatory strategies, tactics, and risk assessments related to regulatory filings. Review and approve external communications, advertising, and promotional labeling to ensure compliance with corporate policies and applicable laws. Oversee project planning, ensuring priorities are set and key milestones are met in a timely manner. Manage collaborations with contract research organizations (CROs) or external partners, ensuring global submissions align with regulatory requirements. Maintain up-to-date knowledge of the global regulatory landscape, competitive trends, and regulatory guidelines. Establish and direct global benefit-risk strategies for products at all stages of development, including pre-market, post-market, and lifecycle management. Perform other duties as necessary, depending on organizational needs. Qualifications Bachelor's degree in a scientific discipline (advanced degree such as Ph.D. or PharmD preferred) 15+ years of experience in Regulatory Affairs within the pharmaceutical or biotech industries Must have experience in the rare disease space Demonstrated ability to design and implement regulatory strategies for innovative products. In-depth understanding of FDA regulations, ICH guidelines, and the drug development process. Experience preparing regulatory submissions, including INDs and clinical trial documents. Prior experience with clinical trials and regulatory documentation is required. Experience with inhalation products, biologics, or related areas is preferred. Comfortable working in a fast-paced, high-visibility environment with evolving priorities. Willingness to travel up to 15%

US$290000 - US$365000 per annum
Boston
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Senior Regulatory Affairs Quality Systems Specialist

Title: Senior Regulatory Affairs and Quality Systems Specialist The Regulatory Affairs and Quality Systems Specialist is responsible for supporting regulatory and quality assurance processes related to in vitro diagnostic (IVD) medical devices. This organization offers a dynamic and collaborative work environment where you have the opportunity to make a meaningful impact in the field of medical diagnostics. With a focus on innovation and excellence, this company provides ample opportunities for professional growth and development, supporting career advancement through hands-on experience and cross-functional collaboration. You will be empowered to contribute to projects that improve healthcare outcomes globally, particularly in the realm of in vitro diagnostic devices. Key Responsibilities Project Compliance and Oversight: Attend project meetings to ensure all medical device design, development, and manufacturing activities meet regulatory requirements, including U.S. FDA's QSR (21 CFR Part 820), ISO 13485, and other relevant standards. Regulatory Strategy Support: Collaborate with internal teams and external partners to develop and implement a global regulatory strategy to meet U.S. FDA requirements and support business goals. Quality System Management: Assist in the management of the organization's Quality System in relation to bringing medical device products to market, including document control and regulatory compliance. Regulatory Submissions: Provide guidance and support in the drafting and submission of regulatory filings, with a particular focus on FDA Q-Submissions and premarket notifications. Clinical and Validation Support: Assist in the preparation and review of technical documents, protocols, and data for clinical trials, validation, verification, and product manufacturing. Regulatory Documentation Management: Maintain regulatory files and databases to ensure accuracy and continuity of information across various platforms. Process Improvement and SOPs: Draft and update Standard Operating Procedures (SOPs) to ensure they reflect current regulatory practices and requirements. Post-market Activities: Manage adverse event reporting, medical device recalls, and product corrections/removals. Product Labeling Oversight: Ensure that product labeling, including Instructions for Use (IFU), complies with all applicable regulatory requirements. Risk Management and Lifecycle Support: Contribute to risk management activities and assist in monitoring product lifecycle changes. Third-Party Audits: Participate in internal and supplier audits, ensuring compliance with regulatory standards and quality system requirements. Qualifications Language Skills: Fluency in English (written and verbal) and Korean (written and verbal) is a Must Bachelor's degree in Engineering, Biology, Biochemistry, Microbiology, or a related field. 5-6 years of experience in a regulated industry, particularly in medical device quality assurance, regulatory affairs, or quality systems management. Experience with FDA and ISO 13485 regulations, including knowledge of IVD medical device regulations, risk management, and design controls. Regulatory Expertise: In-depth knowledge of FDA QSR (21 CFR Part 820), ISO 13485, and other relevant standards for medical device manufacturing. Problem Solving and Adaptability: Ability to adjust strategies and plans as business needs evolve. Stakeholder Communication: Strong interpersonal and communication skills to influence and align stakeholders across the organization. Leadership and Organization: Demonstrated leadership ability and project management skills in fast-paced environments. Technical Writing: Ability to draft and review complex technical documentation, regulatory submissions, and SOPs. Attention to Detail: High level of accuracy in data management and documentation. Time Management: Ability to prioritize multiple projects and meet deadlines in a dynamic environment. Public Speaking and Training: Experience speaking in large group settings and training teams on regulatory and quality requirements. Software Skills: Proficiency with MS Office (Word, Excel, PowerPoint, Outlook) is required. Travel Requirements: Must be willing to travel to US and international based offices

US$90000 - US$120000 per annum
Cincinnati
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Director Regulatory Affairs

Director of Regulatory Affairs Strategy This position is with a rapidly growing pharmaceutical company known for its commitment to advancing transformative therapies. In this role you will have a unique opportunity to lead regulatory strategies for innovative pharmaceutical products, making a meaningful impact on patient health. You'll collaborate with cross-functional teams and engage directly with regulatory agencies, influencing critical decisions in drug development. Key Responsibilities: Oversee daily regulatory activities for projects involving compounds in development or on the market, including submission strategies and regulatory intelligence. Collaborate with Project Teams to develop regulatory and product strategies, including drafting labeling and NDA package inserts. Work with various departments to formulate and execute effective Regulatory Strategies, assessing and communicating regulatory risks and opportunities. Manage submissions and maintenance of INDs, NDAs, MAAs, and related documents. Support due diligence activities for potential product acquisitions or partnerships. Serve as the primary regulatory contact with agencies, including the FDA, and represent the regulatory function in key meetings. Monitor the regulatory landscape and communicate updates to stakeholders. Advise on regulatory requirements to support business strategies, providing expert guidance on scientific and medical issues. Qualifications: Bachelor's degree in life sciences or related field; advanced degree preferred. Minimum 10 years of experience in pharmaceutical regulatory drug development. Proven track record in new chemical entity and line extension filings. Experience interacting with global health authorities and conducting due diligence. Strong knowledge of global pharmaceutical regulations and excellent communication skills.

Up to US$225000 per annum
Philadelphia
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Experience Consultant - US FDA 510k Project

EPM Scientific are looking for a team of experienced consultants, to join our Medical Device client based near Copenhagen, Denmark. The initial project is focussed around a 510k submission, once completed focus will shift towards improving and maintaing compliance to ISO 13485. We are looking for consultants across the following verticals: Regulatory Affairs Quality Assurance Quality Control Validation Software Cyber Security Training & Education Skills & Experience: 10+ years in the Medical Device Industry Strong understanding of ISO 13485 Experience working with SaMD FDA 510k experience (preffered) IEC 62304 & EN 60601 (preffered) Contract Info: Start: January 2025 Duration: 12 months Hours: Full time, 40 hours Location: Denmark (Hybrid)

Negotiable
Denmark
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Director, Global Regulatory Affairs

**Director, Global Regulatory Affairs - West Coast** A high-level position is now open for an exceptional Director of Global Regulatory Affairs based on the West Coast. This role offers the opportunity to spearhead regulatory strategies, navigate product development complexities and ensure compliance across international markets. As the guiding force behind our company's regulatory approach, your influence will be key to shaping market access and maintaining rigorous adherence to worldwide regulations. You'll join a dynamic team committed not only to innovation, but also exemplary standards that keep us at the forefront of our industry. **Role Responsibilities:** - Develop and implement cutting-edge Global regulatory strategies for clinical studies, marketing approvals, development plans and risk assessment, acting as the lead for the global regulatory program. - Prepare comprehensive submissions for Health Authority review. - Lead successful meetings with various global Health Authorities. - Manage regional teams towards cohesive global compliance efforts. - Provide High level oversight, direction, and mentorship to the team for general regulatory strategies and projects. - Reporting to CEO, CSO - Lead the submissions process **Skills Required:** *Regulatory Expertise*: 15+ years in the pharmaceutical industry, with deep understanding of pharmaceutical regulations necessary for steering products through complex approval processes globally. This candidate must have experience with gaining approval for new drug applications and biologic applications, as well as marketing authorizations, utilizing in house teams for the development of these products/submissions. *Strategic Guidance*: Ability provide long-term vision aligning with business objectives, and experience in managing early to late stage products, as well as post approval phases. This role will be leading the development of the company's global regulatory strategy *Leadership Abilities*: Superior managerial skill set fostering collaborative environment goal-oriented outcomes *Health Authority Interaction*: Must have experience leading FDA and/or EMA interactions/meetings This is an exciting opportunity to join a growing team that will make a difference in under-served patient's lives. If you have interest, please apply below.

Negotiable
San Francisco
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Regulatory Affairs Manager

Title: Regulatory Affairs Manager Summary: A leading global medical device company is seeking a Manager of Regulatory Affairs to join their innovative team. This key role involves managing regulatory submissions, including 510(k) filings, and working with both the US FDA and EU EMA to ensure compliance with regulatory standards. The Manager will collaborate with cross-functional teams to develop and execute regulatory strategies, prepare high-quality documentation, and support product development efforts. This position offers an exciting opportunity to contribute to the advancement of cutting-edge medical technologies that improve patient outcomes worldwide. The Manager will be responsible for… Offering guidance, leadership, and coaching to Regulatory Affairs (RA) Associates. Providing expert technical advice on regulatory requirements for new products and modifications to existing ones. Managing, preparing, and reviewing regulatory submissions, including 510(k) filings and compliance with EU MDR standards. Collaborating with departments and cross-functional teams to communicate regulatory strategies effectively. Evaluating advertising and promotional materials to ensure alignment with local and international regulations. The Manager should have the following qualifications: Holds a bachelor's degree in engineering or physical/biological sciences. Possesses 8 years of experience in Regulatory Affairs, including 1+ year of direct or indirect management experience. Extensive experience with 510(k) filings and EU MDR submissions. Comprehensive knowledge of U.S. and international regulatory requirements for medical devices. Proven ability to provide leadership and mentorship to less experienced team members. Skilled in identifying, understanding, and resolving regulatory challenges.

Negotiable
England
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Regulatory News & Insights

Life Sciences Salary Guides of 2023 Image
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Life Sciences Salary Guides of 2023

Are you aiming to advance your career within the life sciences sector? Are you interested in discovering your competitors‘ offerings for professionals in your field across the APAC region? We are excited to present our new series of Salary Guides for the life sciences industry. These comprehensive reports will furnish you with invaluable insights into the present salary trends in Singapore, China, Australia, South Korea, and Japan.Compiled from the responses of almost 900 life sciences professionals in the APAC region, this is an opportunity you shouldn't overlook. Seize the chance to gain a competitive advantage in the life sciences field, enabling you to make well-informed choices about your career trajectory, compensation, and hiring approaches.

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The Life Sciences Skills Gap: How to Hire Image
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The Life Sciences Skills Gap: How to Hire

​The life sciences industry is rapidly growing, but it is experiencing skills gaps that need to be addressed to allow it to reach its full potential. According to a 2022 life sciences and pharma talent trends report, 33% of C-suite and human capital leaders in the life sciences and pharmaceuticals sector agree that talent scarcity is a major pain point. This problem is widespread, with the UK also suffering a skills shortage that threatens to stall the industry’s trajectory.Skills gaps in digital and computational skills, and industrial, economic, and clinical research are particularly large. However, if phenotypic, genomic, and patient data integration practices can be optimized across the industry, this will support both research and treatment advances in the future.This article shares effective hiring strategies that can help life sciences organizations address skill gaps within their teams and wider business.Understanding the skills gaps in the life sciences industryStatistics from the talent trends report highlight the key skills gaps in the life sciences industry and how they impact key research and development processes. Demand for life sciences products is forecast to grow more rapidly than the global GDP over the coming years, and 45% of the aforementioned talent leaders note that they are looking to hire primarily to avoid talent scarcity from hindering their organizations’ progress. Moreover, the report found that 67% of pharmaceutical and life sciences companies believe that reskilling their current employees is an efficient way to address and mitigate skills gaps. It currently takes 105 days on average to fill a non-executive life sciences position in the US, leading to financial losses of $500 per open role per day, so intentional talent strategies are crucial to setting life sciences businesses on the path to success.Supporting mobility between sectorsSupporting mobility between sectors plays a vital role in closing the skills gaps within the life sciences industry. Enabling professionals to transition across sectors, ranging from Regulatory and Legal Services to Pharmaceutical and Medical Device Engineering, allows life sciences companies to tap into a vast pool of talent. This is also an effective method of sharing intersectional knowledge and developing key skills.Selecting candidates with a diverse range of backgrounds for open roles may also bring more unique perspectives into your organization, thereby driving innovation and helping to meet growing demand. Focus on transferable skillsFocusing on transferable skills is a powerful approach to bridging the skills gap in the life sciences industry. Rather than solely emphasizing sector-specific experience, prioritizing transferable skills enables professionals to adapt and thrive in new roles within the field. The life sciences industry’s talent offers a myriad of transferable skills that can be used to power future growth and innovation. These include analytical skills, leadership and teamwork skills, problem solving, written and oral communication skills, management skills, and scientific peer communication. Additional soft skills to focus on in your talent acquisition strategy include critical thinking, problem solving, and attention to detail.Consider cultural fitSeek out candidates from other industries who align with your organization’s culture, values, and core mission. This alignment promotes employee engagement, retention, and overall job satisfaction, whilst creating a supportive working environment that benefits from a wide range of experiences and perspectives.These candidates should also possess the aforementioned transferable skills, which will help to ensure that they can perform optimally in their new roles without being hindered by common skills gaps.Offer more flexibilityWhile not a priority for all candidates, flexible working arrangements such as remote or hybrid work arrangements are valuable to skilled candidates and may help to give your organization an advantage in the ongoing competition for life sciences talent.Hire top talent with EPM ScientificEPM Scientific is a leading specialist life sciences talent partner, providing you with a wealth of expertise to help you locate the best talent for your life sciences roles globally. Submit a vacancy or request a call back from our team to find the right people to drive your organization forwards.

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How to Ensure Employee Retention in Life Sciences Image
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How to Ensure Employee Retention in Life Sciences

​The Pharmaceutical market has expanded considerably in the past two decades, with Pharma revenues totalling $1.42tn in 2021. This has been accompanied by a growing demand for experienced, highly qualified Life Sciences professionals: with more drugs than ever now available, companies require a strong workforce to bring their products to market. The industry has had to deal with an ever-small talent pool as a result, which has been exacerbated by one of the highest employee churn rates, with the Life Sciences and Medical Devices industry alone seeing a 20.6% turnover rate. This is reflected in the results of our Life Sciences survey which revealed that more than 40% of Life Sciences professionals are currently looking for a new role.The COVID-19 pandemic led to a substantial increase in resignations across all industries, as many employees started to re-evaluate their priorities and seek roles that offered flexible remote-work policies. Consequently, companies have found it harder to get the people they need. 47.8 million workers in the U.S. decided to quit their jobs in 2021 – the highest volume of resignations since the Bureau of Labor Statistics began recording this data in 2001. This is equivalent to 3.98 million workers quitting their jobs each month, up from an average of roughly 3m leaving their jobs each month in 2019.Similar trends have been observed in Australia and the UK, where the rate of employed people between 16-64 choosing to switch jobs reached an all-time high of 3.2% between October-December 2021. The resignation rate continued to increase in 2022, with job-to-job resignations in the UK peaking at 442,000 in the second quarter of 2022. In Europe, one in three workers are considering quitting their jobs in the near term, with inadequate compensation and lack of career advancement being cited as the top factors.Why are Life Sciences professionals leaving their roles?The reasons that Life Sciences professionals have for wanting to leave their jobs vary across each industry sector. However, the promise of higher remuneration is invariably the main reason. This is according to findings from our Year in Review, which goes into greater depth about the factors that matter most to Life Sciences professionals when seeking to advance their careers.There are a host of other important factors, however, such as the desire for an improved work-life balance and employees wanting to acquire more new skills that will aid in their professional development. Changes in management can also cause people to want to move jobs, and Life Sciences professionals are increasingly looking for openings that provide flexible working hours and the ability to work from home.How to improve employee retentionThe good news is that there is a wide range of employee retention strategies that you can adopt in your workplace. Let’s take a look at some of the most effective employee retention techniques that you can use to ensure that your employees are satisfied at work and remain highly motivated in their positions, as opposed to looking elsewhere for their big career break.Offer competitive salaries and benefitsDissatisfaction around salary has had a negative impact on talent retention in the Life Sciences sector. As we’ve seen across the board, wanting higher compensation is the top reason for employees wanting to move to jobs; 70% of the R&D professionals that we surveyed within the Pharmacological industry were motivated by the promise of higher compensation at other companies.Paying your team a competitive rate is a simple but effective employee retention strategy that you can use to avoid your workforce shrinking. Our survey results show that the majority of respondents want a pay rise upwards of 10-15% of their current salary, which provides some indication of how much you may need to offer in order to remain competitive. Focus on career developmentYour employees will be far less likely to want to continue working for you long-term if there are few opportunities for advancement – or if their ability to develop their skills is limited. A study by Work Institute found that employees quit in 20% of cases due to career development issues.This highlights the importance of setting clear paths for career progression to give your team the motivation and provide them with long-term goals.Be flexibleOffering flexible working arrangements is a sure-fire way to keep your employees happy. Our Year in Review revealed that the option to work from home is very important to 60% of the industry as a whole. The majority of R&D respondents deemed flexibility as either important or very important, and workers in Pharmacovigilance ranked flexibility higher than salary when asked what is most important when considering a new job.Whilst a lack of flexible working options will not be a deal-breaker for many employees, you will find it far easier to retain your top talent if you grant them greater freedom to work according to their preferences.Build a supportive company cultureThere’s nothing quite like a warm, friendly culture when it comes to getting excellent work out of your employees. It’s also one of the best ways to increase their loyalty to the company.Seeking feedback from employees on a regular basis about how working processes might be improved helps ensure that workers feel that their concerns are being heard and addressed. Providing senior employees with the skills and training that they need to be good managers is also a worthwhile endeavour. Manufacturing professionals regard good leadership as almost as important as salary, according to our Year in Review survey.Promote work-life balanceMore than a third of respondents in our Life Sciences Year in Review report highlighted a poor work-life balance as one of the main reasons for wanting to seek employment in another role. Almost half of the Clinical Pharmacology professionals surveyed cited a need for an improved work-life balance as their main reason for seeking a new position.With higher numbers of professionals re-evaluating their priorities in life in the wake of the COVID pandemic, it’s no wonder that Life Sciences professionals are seeking out positions that allow them to spend more time with their families and friends. Giving your employees more personal time is therefore one of the most effective strategies for employee retention.Offer innovative, up-to-date technologiesFinally, ensure that you have the latest technology in your workplace. Investing in top-of-the-range software, for example, will make it easier for your employees to complete tasks and reduce the errors that are made, thereby increasing company productivity and boosting morale.Employee retention is critical to successThriving companies are characterized by a happy, satisfied workforce and high employee retention rates. Partner with EPM Scientific, a leading executive search firm for the Life Sciences industry, to find out more about how you can implement employee retention strategies that get results. Request a call back and one of our specialist consultants will be in touch. ​

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How to Determine if a New Hire Will Fit into Your Company's Culture Image
Management & Culture

How to Determine if a New Hire Will Fit into Your Company's Culture

There’s no question that a company’s culture and ethos can help its employees feel more satisfied at work, increase employee retention and ultimately serve as a catalyst for its success. Company culture is seen as very important by professionals: survey data collected by Glassdoor shows that more than three quarters of professionals take the culture into account before applying for a job, and 56% say that they see the culture of a company as playing a more significant role than salary in determining overall job satisfaction. Given the role that it plays, cultural fit should be a key priority for employers.Why is cultural fit important?If somebody is a good cultural fit for a company, they are far more likely to be an engaged, motivated employee who derives satisfaction from their role. There is a greater chance that they will see the job as more than just a source of income and as such, they will be more likely to go above and beyond in the workplace and may even inspire others to follow in their footsteps.Hiring for cultural fit therefore makes good business sense. 10-25% of new employees decide to leave within six months of starting work, and one reason that professionals give for quitting is that they feel that they are a poor fit for the company culture. Choosing people for the job who are a natural fit for the company’s values and working practices is a great way to avoid these problems from arising.How to hire for cultural fit?Given the importance of company culture, businesses are increasingly hiring for cultural fit. This involves defining what your culture is all about and incorporating questions at interview stage that relate to your interviewees’ values, motivations and aspirations.Define your company’s cultureThe first step is to describe your company’s culture in writing. What are the values, beliefs and ethics that characterize your company’s operations and working environment? If you are struggling to capture the essence of your culture, it might be worth asking current employees about how they feel about the company and its working practices. It is recommended that you use such feedback when writing or updating a mission statement and articulating your company values. Include these on your website and on all your digital platforms, in addition to testimonials from your current employees.Demonstrate your values throughout the interview processAsking values-based interview questions is one of the best ways to identify candidates who share your values and will be a good fit in the workplace.You should also draw attention to the benefits that you offer your employees. 56% of CFOs in the Asia-Pacific (APAC) have said that they are considering expanding benefits, including flexible working arrangements (FWAs), in a bid to retain their top talent. If you offer flexible working roles, ensure that your staff relay this information at interview stage.Cover the right questionsIf you’re wondering how to determine if a candidate is a good fit, asking the following questions will help shed light on the personality of your interviewees and their alignment with your values:What motivates you? How do you handle conflict in the workplace?What work environment supports innovation and productivity levels? Give me an example of something that you have taught yourself in the last six monthsWhat experiences have shaped your outlook on life?What are you most proud of?Utilize personality testsPersonality tests provide valuable insights into how prospective employees approach problems. They can also shed light on their ability to work alongside others and offer further information about their interests and preferences.Some of the most common personality tests used by employers include the Myers-Briggs Type Indicator, the Caliper Profile and the 16 Personality Factor Questionnaire.Other key considerationsWhilst cultural fit is of great importance, it should be weighed alongside other factors. Hiring solely for cultural fit can perpetuate bias and lead to a lack of diversity within the workplace as a result. It’s also important to take into consideration an applicant’s qualifications, work experience, career aspirations and skill set when assessing their suitability for a role in your organization.Secure Life Sciences Talent with EPM ScientificAre you looking to solve your talent challenges? EPM Scientific offers bespoke talent solutions across Life Sciences A combination of our specialist account management service, ongoing support and reporting, and hiring advice allows us to find you exactly the people you need, when you need them. Register your vacancy or request a call back today.Our Talent Expertise​​​

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Negotiating the salary you deserve  Image
regulatory

Negotiating the salary you deserve 

​When seeking a new job, it’s imperative to know the market, understand where you fit within it, and form a realistic salary expectation to stick to. A good talent partner will help you to know your worth within the industry and organization you’re interviewing for and will assist with communicating those expectations back to the hiring manager, but no one is a better advocate for you than you. ​Learning how to negotiate a salary when you receive a job offer is a vital skill for both now and in the future, and when done appropriately, will put you in a better position not just financially, but also in terms of how valued you feel in your role. We know that feeling appreciated and adequately compensated for our time, effort, and expertise has a direct impact on productivity, engagement, and general happiness within a company, so salary negotiations play an important part for both sides.​It can be difficult to communicate those expectations as a professional hoping to onboard with a new company, and there is certainly a residual stigma around speaking about money and asking for more that is hard to overcome. At EPM Scientific, we have observed that professionals who negotiate their salary are presented with a much better job offer, so good communication skills and an understanding of your contribution can really pay off. ​As a general rule, always assume the offer is up for negotiation. And don’t forget to approach the process with positivity, as chances are the hiring manager isn’t crazy about negotiating, either. Here are our top tips on how to negotiate for the salary you deserve.​Know the industry salary trends​Trying to negotiate for a higher salary without being familiar with industry trends will get you off to a bad start. Information is your biggest asset and conducting some research as well as speaking openly to a talent partner that knows your industry, the hiring company, and what you have to offer, will vastly improve your bargaining power. You can be a negotiating pro, but without being able to back up your requests with solid reasoning, it will be harder for the hiring company to take your expectations seriously. ​Pay particular attention to the most sought-after roles and skills within your industry and think about how your experience relates. Being able to recognize when your skills are transferable to a particularly in-demand area will add to your negotiation power. ​Start negotiating only when you have a firm offer​There is a process to be followed when it comes to receiving and accepting a job offer and understanding the etiquette will help your negotiation when the time comes. If you are interested in a position but it doesn’t meet your salary expectation, resist the temptation to bargain until the company has given you a formal offer. This is your signal that your skills, expertise, and personality are a strong match for the business and the role, and is a great asset to you when it’s time to tell them why you’re worth the higher salary. Once the ball is in your court, you can use the fact that they think you’re right for the job along with your understanding of the industry and the market to your advantage, making it harder for them to dismiss your requirements.It can also be worthwhile to take a reasonable amount of time to consider the offer rather than jump into negotiations. Tell the hiring manager that you’re serious about the offer and the position, but that you need some time to consider the whole picture. Be gracious and enthusiastic but take the time you need to prepare for negotiations and signal to them that there may be elements of the offer that don’t align with your requirements. Chances are they’ll have a counteroffer in mind for you.Build the business caseIn order for a company to seriously consider your request for an increased salary offer, it must make commercial sense for the business. Make a strong case, show that you understand the company's current financial situation, and know who has the power to negotiate. While likeability shouldn’t be underestimated in the hiring process and a large part of your job offer will be to do with character fit, it’s not enough for them to like you when it comes to financial compensation. They have to believe your worth in fiscal terms, so don’t expect your personal compatibility to get you the salary increase you want. Instead, explain precisely why your requirements are justified in a business sense; your glowing personality will just make them glad your business case checked out.Suggest an exact number for your salaryTime is of the essence, and hiring managers are particularly strapped for it while conducting interviews alongside their other duties. Therefore, they’ll likely appreciate a direct approach to your negotiation in terms of giving them the exact offer you’re looking for. It can be a powerful strategy in that it keeps the ball rolling and avoids pointless back and forth. Many studies suggest that candidates who use a specific number end up with a final offer much closer to the figure they were hoping for. Your potential employer will assume you have done your research on your market value and want to stay competitive in their offer. Don't suggest a range – you will always get offered the lowest if the manager knows there's room to haggle down.Reveal your current salary when negotiatingOutside the US, the hiring manager may ask what you are currently earning, which can be awkward if you feel you are currently being underpaid. It might be tempting to lie and state a higher salary more in line with what you’re seeking, but if you're unhappy with your current pay, it can be valuable to tell them why. Include all your benefits, bonuses and confidently explain the figure you're hoping for while making the case for why. If anything, they’ll have a more genuine understanding of what you know your worth to be, and that salary is important enough for you to walk away from a role that isn’t aligned with your requirements.Have a walk away pointKnow your limits and your expectations and keep them firmly in mind. Have a pre-considered ‘walk away’ point - the figure you’re absolutely unwilling to drop below. Base this on your financial need and the market value of the role, but keep in mind the role itself. Why are you interviewing for the position in the first place? Is your passion for the work worth lowering your salary expectations? Get help negotiating your salarySpeaking with a specialist talent partner will help you understand your worth in the context of current industry trends and the wider job market, too. At EPM Scientific, we can evaluate your profile against the wider talent pool, as well as align your expectations with that of our current database of hiring companies. We'll help you pitch your value at the right price during the salary negotiation process, giving you the best chance to make your next position a rewarding and fulfilling one. Get in touch for tailored advice.

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