Our client is a leading beauty company that is looking for a new Senior Regulatory Affairs Manager to join their team!
About the Role:
The Senior Regulatory Affairs Manager ensures regulatory compliance of cosmetic, OTC, dietary supplement, and device products from brief through launch in North America. Specifically, the Sr. Manager will assemble and review all product-related information including formulas, specifications, and quality/regulatory compliance documentation, and for approving claims, labeling, and advertising. Communicate emerging regulations to key stakeholders and their impact on companies brand portfolio.
This role will report to the Head of Sr. RA Manager.
Specific Duties and Responsibilities:
- Participate in project teams in assigned categories to ensure completion of appropriate documents during the development process through final formula approval and launch
- Maintain and ensure compliance with companies ingredient policies and appropriate product regulations
- Ensure claims are compliant with company and local regulatory requirements and consistent across labels, advertising, and other consumer communications
- review and approve NA artworks
- Responsible for US regulatory submissions, including FDA drug and establishment registrations, supplement notifications, WERCS and EPA and state pesticide registrations
- Assist monitoring US state and federal regulations impacting the cosmetic and personal care industry including OTC
- Support with upcoming changes in the regulations including any specific monitoring and implementation for states, e.g., California
- Scientific degree
- Over 8 years of Regulatory Affairs experience within a regulated industry, preferably skin and personal care products including OTC
- Product development experience strongly preferred
- Skin and personal care including OTC claim review experience strongly preferred
- Track record adhering to compliance requirements (i.e. FDA, Health Canada, EPA, FTC, cGMP, ISO, etc.)
- Strong written communication skills, especially detail oriented and technical material
- Experience communicating with cross-functional teams and customers including verbal presentations
- Ability to work effectively both independently and as part of a team
- Ability to meet deadlines while being flexible to changes in priorities and interruptions
- Excellent organizational and analytical skills to complete assignments accurately
- full usability of MS Office suite (Excel, Word, Outlook, PowerPoint)