Global Regulatory Affairs Manager

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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