What are the responsibilities and job description for the Global Regulatory Affairs Manager position at Fourth Floor?
Our client, a fragrance manufacturer, is seeking a Global Regulatory Affairs Manager to join their team in NYC!
Responsibilities:
- Oversee all product submission processes to ensure efficiency, compliance and timely launches of products globally.
- Processes include product registration/notifications (e.g. CPNP, CNF, MoCRA, etc.), other product/packaging reporting, country specific product regulatory requirements management and tracking of submissions globally.
- Create and review regulatory documentation including Certificates of Compliance, ingredient listing, quantitative and qualitative documentation & label claim reviews.
- Prepare international regulatory submissions, progress reports, supplements and amendments, license renewal and annual registrations.
- Responsible for engagement strategy with key stakeholders.
- Work collaboratively with Product Development, Marketing, Sales, Legal, Quality and Operations to evaluate risks and provide risk assessments to the key stakeholders.
- Monitor launch timelines to ensure sufficient lead times for registration.
- Organize and maintain regulatory files with records required to meet federal and international standards.
- Troubleshoot and resolve registration requests/inquiries.
- Update the business on registration status globally.
Qualifications:
- Bachelor's Degree
- 5-7 years of experience in Regulatory Affairs
- Experience in the beauty industry a must, preferably in fragrance
- Demonstrated experience in the preparation and submission of regulatory documents.
- Must have a solid understanding of regulations surrounding cosmetics including US-FDA, FPLA (Fair Packaging and Labeling Act), FDC (Food, Drug, & Cosmetic Act), EU Cosmetic Regulation 1223/2009, and Health Canada regulations. Experience with other global regulations, including China regulations/registrations a plus.
- General understanding of overall manufacturing and quality processes.
Please submit your resume for consideration.
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Salary : $90,000 - $110,000