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Manager, Regulatory Affairs
Posted 10 days agoViewed
💎 Seniority level: Manager, 5+ years
💸 Salary: 90000.0 - 115000.0 USD per year
🏢 Company: AG1
🗣️ Languages: English
⏳ Experience: 5+ years
Requirements:
- Minimum of 5+ years of demonstrated International Regulatory Affairs experience (EU, UK and other global regions).
- Science background preferred, with understanding of technical documents such as Certificates of Analysis, Certificates of Composition, Safety Data Sheets, Certifications, etc.
- Strong knowledge of international dietary supplement regulations, specifically EFSA. MPI, MedSafe, TGA, CFDA, and other relevant authorities a plus.
- Demonstrated experience in ingredient, formula and label review.
Responsibilities:
- Partner with RNI, Supply Chain/Procurement and Quality Departments to provide guidance on international formulation compliance, labeling, and marketing claims in accordance with regional laws and guidelines.
- Serve as the primary liaison with external consultants that work on supporting compliance reviews for our international product portfolio.
- Integrate Regulatory timelines into the product development timelines to ensure end-to-end review and compliance of our current and future product iterations.
- Gather and review raw material/finished product information required for the development of label information to create applicable preliminary supplement fact reports.
- Manage the creation, review, and approval of Label Specification Sheets (LSS), including supplement panels, ingredient/allergen statements and required warnings/disclosures for existing and emerging markets.
- Collaborate with cross-functional, and cross-market, AG1 teams to inspect label artwork for accuracy and compliance against Label Specification Sheets, share recommended changes and collect the necessary approval(s) of all international artwork.
- Effectively manage the product registration submissions for our core and innovation products across multiple jurisdictions, in partnership with Quality and Legal leadership.
- Manage post-market surveillance regulatory activities, when applicable across global markets.
- Assist with documenting processes and procedures for the Regulatory Affairs team, as well as supporting policy development through research and recommendations on positions related to labeling and regulatory.
- Stay up to date with evolving regulatory requirements across the globe, ensuring compliance with applicable laws and standards (e.g., US, EU, UK, APAC, LATAM).
- Support our culture of Continuous Improvement by helping identify waste/inefficiencies/errors in systems and processes, assessing root causes, and then working with the teams to eliminate the issues.
- Perform other duties as needed.
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