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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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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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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Senior Regulatory Affairs Executive
Job Title: Senior Regulatory Affairs Executive Location: Singapore Job Type: Full-Time Our client is a dynamic and innovative pharmaceutical company, dedicated to improving patient outcomes through cutting-edge research and development. They are committed to maintaining the highest standards of regulatory compliance and ensuring the safety and efficacy of our products. Job Responsibilities: Regulatory Strategy: Develop and implement regulatory strategies to ensure timely approval of new products and maintenance of existing product licenses. Submission Management: Prepare, review, and submit regulatory documents to health authorities, including the Health Sciences Authority (HSA) in Singapore. Compliance: Ensure compliance with local and international regulatory requirements, guidelines, and standards. Liaison: Act as the primary point of contact with regulatory agencies, responding to queries and providing necessary documentation. Cross-Functional Collaboration: Work closely with R&D, Quality Assurance, and Marketing teams to ensure regulatory requirements are met throughout the product lifecycle. Regulatory Intelligence: Stay updated on regulatory changes and trends, and provide guidance to internal teams on potential impacts. Training: Provide training and support to junior regulatory staff and other departments on regulatory affairs processes and requirements. Qualifications: Education: Bachelor's degree in Pharmacy, Life Sciences, or a related field. Advanced degree preferred. Experience: Minimum of 5 years of experience in regulatory affairs within the pharmaceutical industry. Knowledge: In-depth knowledge of local and international regulatory requirements, including ICH guidelines and ASEAN regulations. Skills: Excellent communication, organizational, and project management skills. Ability to work independently and as part of a team. Attention to Detail: Strong attention to detail and ability to manage multiple projects simultaneously.
Negotiable
Singapore
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Regulatory Affairs, Contractor
Regulatory Affairs Contractor (Remote, USA) As a Regulatory Affairs Contractor, you will support the development and implementation of global regulatory CMC strategies for our partners' marketed and development products. You will assist with regulatory activities for both internal and external programs, working closely with cross-functional subject matter experts to ensure effective partnerships, regulatory compliance, and timely submission and approval of global regulatory filings. Responsibilities: Review regulatory submission documents and support regulatory filings Interpret regulations and provide well-reasoned regulatory guidance to cross-functional project teams Support and lead in the preparation of health authority meeting materials and lead responses to requests for information Research, prepare, and present on global regulatory topics to internal and external collaborators Ensure compliance with all applicable regulations, including regulatory change management Requirements: A minimum of a BS degree in science with at least 3 years of experience in Regulatory Affairs CMC in the biotech/pharmaceutical industry (an equivalent combination of education and experience will be considered) Proven experience with Health Authorities submissions and a working knowledge of FDA/EMA regulations Proven experience and success in applying regulatory knowledge to various situations Excellent writing, communication, and interpretive skills Experience with European/global submissions is a plus Experience in regulatory management of commercial products is a plus.
Negotiable
United States of America
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Regulatory Affairs Manager
Job Title: Regulatory Affairs Manager Location: Seoul, Korea Our client is a leading innovator in the medical device industry, dedicated to improving patient outcomes through cutting-edge technology and exceptional quality. They are committed to compliance with global regulatory standards and are seeking a talented Regulatory Affairs Manager to join the team. Key Responsibilities: Regulatory Strategy: Develop and implement regulatory strategies to ensure timely approval of medical devices in Korea and other target markets. Submissions: Prepare, review, and submit regulatory documents, including pre-market notifications, technical files, and clinical trial applications to regulatory authorities such as the Ministry of Food and Drug Safety (MFDS). Compliance: Ensure compliance with local and international regulations, standards, and guidelines, including ISO 13485, MDR, and FDA requirements. Liaison: Act as the primary contact with regulatory agencies, managing communications and negotiations to facilitate approvals and resolve issues. Documentation: Maintain and update regulatory documentation, including product registrations, labeling, and promotional materials. Training: Provide training and guidance to internal teams on regulatory requirements and changes in the regulatory landscape. Audits: Support regulatory inspections and audits, ensuring readiness and compliance. Requirements: Education: Bachelor's degree in a scientific discipline (e.g., Biology, Chemistry, Biomedical Engineering, Pharmacy) or related field. Experience: Minimum 5 years of experience in regulatory affairs within the medical device industry, with a strong understanding of Korean and international regulations (US FDA, etc.). Skills: Excellent written and verbal communication skills in both Korean and English. Strong analytical and problem-solving abilities. Knowledge: In-depth knowledge of regulatory requirements and standards, including ISO 13485, MDR, and FDA regulations. Language Proficiency: Fluent in both Korean and English languages.
Negotiable
Seoul
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Head of Quality and Regulatory
Title: Head of Regulatory and Quality Summary: Join a pioneering leader in medical technology dedicated to advancing patient care and safety. Our client is at the forefront of developing innovative solutions that address critical gaps in diagnostic accuracy and infection prevention. As the Head of Regulatory and Quality, you will play a pivotal role in shaping the regulatory strategy, ensuring compliance and driving quality initiatives that align with our mission to deliver life-changing medical innovations. If you're a result driven professional with a passion for fostering excellence and ensuring the highest standards, we invite you to lead and inspire our dynamic team in transforming healthcare. The RA/QA Head will be responsible for… Guide and mentor the Quality and Regulatory team, setting goals, providing feedback, and fostering professional growth to drive organizational excellence. Manage regulatory submissions (510k and EU MDR), provide expertise on domestic and international requirements, and ensure compliance in labeling, marketing, and product documentation. Oversee the development and enhancement of the Quality Management System, ensuring audit-readiness, adherence to design controls, and proactive resolution of quality issues. Lead post-market activities, including complaint handling, root cause analysis, trend monitoring, vigilance reporting, and responses to regulatory agencies like FDA and ISO. Direct supplier quality controls, collaborate with cross-functional teams on new product development, and ensure regulatory and quality standards in materials, processes, and product launches. The RA/QA Head should have the following qualifications: Bachelor's degree in life sciences, engineering, or a related field required; graduate degree strongly preferred. Over 10 years in medical technology or life sciences, including 5+ years in quality or regulatory roles, with a preference for start-up experience. In-depth knowledge of U.S. and international regulations (21-CFR-820, ISO 13485, MDD, MDR, ISO 14971, ISO 10993), including experience with FDA audits and quality system implementation. Proven ability to manage all phases of product development, from concept through commercialization, ensuring regulatory compliance and operational excellence. Effective in fast-paced, dynamic environments with changing priorities, and open to travel up to 30% of the time.
Negotiable
Seattle
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Regulatory Pharmacist
Job Title: Regulatory Pharmacist Location: Singapore About Us: Our client is a leading innovator in the pharmaceutical industry, dedicated to advancing healthcare through cutting-edge research and development. Our client specializes in developing groundbreaking therapies and medications that address unmet medical needs. With a strong commitment to quality and regulatory compliance, we strive to deliver safe and effective solutions that improve patient outcomes and enhance the quality of life. Key Responsibilities: Ensure compliance with local and international pharmaceutical regulations. Prepare and submit regulatory documents to relevant authorities. Review and approve product labeling, advertising, and promotional materials. Monitor and interpret regulatory changes and ensure timely compliance. Provide regulatory guidance to cross-functional teams during product development. Liaise with regulatory agencies and maintain positive relationships. Conduct internal audits and support external audits. Train and mentor junior regulatory staff. Qualifications: Bachelor's degree in Pharmacy or a related field. Minimum of 3 years of experience in regulatory affairs within the pharmaceutical industry. Strong knowledge of local and international regulations (e.g., HSA, FDA, EMA). Excellent analytical and problem-solving skills. Strong communication and interpersonal skills.
Negotiable
Singapore
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Clinical Evaluation Reporting Specialist
Job Overview The Clinical Evaluation Reporting Specialist is tasked with creating Clinical Evaluation Reports (CERs) for Terumo Blood and Cell Technologies (TBCT) products. This involves utilizing product labeling, preclinical and clinical data, published literature, risk management documents, complaints, post-market surveillance, and adverse event reports. The Specialist coordinates with various departments to gather necessary documentation and directs them on the required information for CERs. Responsibilities include data collection, appraisal, and extraction from safety and performance data, as well as compiling and authoring Systematic Literature Reviews (SLRs), CER assessments, new CERs, and updates. Key Responsibilities Lead the development of CERs by collaborating with stakeholders from Clinical Safety, Quality Assurance, Regulatory Affairs, Clinical Affairs, and other departments to gather relevant documentation. Work with information specialists to conduct systematic literature searches on TBCT products and their equivalents or competitors. Review and appraise published literature to identify relevant articles for the safety and performance of TBCT products. Collaborate across departments to understand regulatory submissions, develop literature search strategies, facilitate SLRs, compile necessary CER inputs, analyze product complaints, conduct adverse event and recall searches, and compile preclinical and clinical data. Author drafts of SLRs, CER assessments, new CERs, and updates based on business and research priorities. Manage document reviews, reconcile comments, and finalize and approve CERs. Provide input on risk management deliverables, clinical research, and literature evidence for product development. Stay updated on CER regulatory requirements for all applicable countries. Develop policies and procedures related to Clinical Evaluation Reviews and Reporting. Train and guide contractors on CER development. Disseminate findings from CER updates. Develop logistics for SLRs and CERs, including deliverables, timelines, and draft reviews. Ensure compliance with all applicable laws, regulations, standards, and company procedures. Minimum Qualifications A graduate degree (e.g., MS, PhD) in a scientific, biological, medical, or regulatory discipline, or equivalent education and experience. Five years of experience with knowledge in research methodology, information management, relevant databases (e.g., PubMed), regulatory requirements, medical writing, systematic review, and clinical data appraisal. Experience in clinical evaluation reporting in academic or medical device/pharmaceutical industry roles. Understanding of clinical research and regulatory guidelines. Skills Leadership and interpersonal skills to develop and maintain interdepartmental relationships. Ability to work independently and as part of a team. Effective prioritization and management of multiple projects. Presentation skills for diverse audiences. Development and implementation of global policies and procedures. Analytical skills for information from multiple sources. Understanding of scientific/clinical research methodology. Knowledge of regulatory processes (e.g., CE Marking, IDE, PMA, 510(k)), GCP procedures, and legal compliance. Proficiency in software programs (e.g., Microsoft Office). Strong writing and critique skills for clinical and regulatory documentation. Project management skills for effective execution and management.
Negotiable
United States of America
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Technical Expert - Active Electromedical Devices
ABOUT US We are a European organization recognized as an official Notified Body under Regulation (EU) 2017/745, specializing in verifying the conformity of medical devices with the stringent requirements of the MDR 2017/745 regulation. Our work ensures that medical devices meet the necessary standards for certification and market entry within the European Union. For our expanding Medical Devices Division, we are seeking an experienced professional to join our team as a Lead Auditor for Active Electromedical Devices (MDR 2017/745). PRIMARY RESPONSIBILITIES In this role, you will: Conduct audits of manufacturers and, where necessary, their suppliers. Assess the technical documentation of assigned medical devices to ensure compliance with MDR 2017/745. Oversee certification processes for a diverse portfolio of international manufacturers of active medical devices. QUALIFICATIONS Educational Background A degree or advanced qualification in scientific fields such as biomedical engineering, bioengineering, physics, electrical engineering, or similar disciplines. Professional Experience Candidates should have: Significant experience in the active medical device industry, focusing on design, manufacturing, technical documentation, or testing; OR Extensive experience with Notified Bodies, including evaluation of technical files and audit activities for active medical devices. Language Skills
Negotiable
Italy
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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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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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