Senior Regulatory Affairs Specialist

Summary:

The Senior Regulatory Affairs Specialist is responsible for managing appropriate regulatory and technical information to ensure regulatory compliance and support product registrations globally. This individual must possess general knowledge of global regulatory requirements relative to regulated products and other areas of responsibility as assigned.

The ideal candidate will have 5+ years of experience in a regulatory role, preferably within cosmetic, pharmaceutical, or medical device.

Essential Job Functions:

• Manage and support global registration/notifications of regulated products.
• Advise management on regulatory matters concerning regulated products and provide guidance for compliance to any new or updated regulations and requirements.
• Write, assemble, and maintain documentation and information to support compliance to regulatory requirements for products sold domestically and internationally.
• Write, assemble, and maintain technical documentation and information to support customer requests, including Safety Data Sheets, Ingredient Lists, Technical Data Sheets, and/or Company Statements.
• Maintain State and Federal product listings, notifications, licensing and establishment registrations.
• Support new product or reformulated product launches.
• Generate and maintain Technical/Product Information Files.
• Where required, coordinate biocompatibility and/or safety assessments of regulated products internally and/or with 3rd party vendors.
• Conduct product labeling and literature review to ensure labeling meets appropriate regulations of the country in which the product will be marketed in.
• Support handling of adverse events. Document and communicate incidents with appropriate Regulatory personnel and notify competent authorities of events that have serious undesirable effects.
• Coordinate and support product recalls with Customers and regulatory bodies or competent authorities.
• Assist with external inspections and/or audits conducted by Regulatory Authorities or Customers.
• Assist with internal audits as assigned by the Quality Assurance department.
• Maintain appropriate documentation, procedures, and quality records.

Qualifications:

• Minimum 5 years relevant experience in a regulated technical function
• Strong interpersonal skills-ability to interface and communicate/collaborate at all levels internally and externally.
• Adept verbal and written communication skills-including technical writing & documentation.
• Excellent organizational and project management skills with ability to track, prioritize, and organize multiple concurrent projects.
• High attention to detail.
• Strong problem solving and multi-tasking skills.

Desired:

• Knowledge of cGMP requirements, ISO standards and/or quality assurance
• Familiarity with international market labeling and registrations
• Knowledge of REACH, OSHA, EU CLP, and GHS labelling and SDS requirements
• Experience using Intelligent Authoring (or similar service) for document generation

Education:

• Bachelor's degree or equivalent, with a strong preference for chemistry or related field desirable.

Benefits and Perks:

• Free lunch daily
• On-site fitness center
• Enriched Medical, Dental, and Vision plans
• Weekly Pay
• Flexible Spending Account (FSA) - Medical & Dependent Care / Health Savings Account (HSA) Options
• 401K Retirement Savings Plan with Safe Harbor - Employer Contribution of 3% Gross Wages
• Tuition Assistance Program
• Company-provided Term Life with Voluntary Term Life/Accident/Disability/Critical Illness/Hospital Indemnity