Lead Associate- OTC
Hybrid · Princeton, New Jersey, United States
Job Summary
Lead Associate for OTC Regulatory Affairs provides regulatory support for OTC commercial operations with responsibilities spanning artwork creation and review, BOM management, NDC assignment and drug listing, participation in OTC meetings with cross-functional teams, compilation of NDA/ANDA annual reports, FDA submissions, post-approval lifecycle coordination with the global RA team, and cross-functional internal support. Responsibilities include artwork management, submission artwork review, BOM review/approval, NDC listings, and representing the RA team in OTC meetings; support for annual reports for NDA/ANDAs; daily regulatory submissions to FDA; launch support for commercial artwork creation and NDC listings; ensure regulatory compliance for marketed products; maintain regulatory document files. Requires 2-5 years in Regulatory Affairs, BS/MS in a scientific discipline, OTC labeling experience, proficiency with 21 CFR 201 labeling, FDA OTC labeling guidance, NDA/ANDA lifecycle, and FDA cGMP awareness; strong organizational, time management, and communication skills. Location: Hybrid – Princeton, NJ (On-Site 4 Days/Week); Assignment length: 6 months with potential extension.
Required Qualifications
- 2-5 years’ experience in Regulatory Affairs
- BS/MS degree in a scientific discipline preferred
- Experience in creation / review and approval of OTC labeling
- Proficiency in 21 CFR 201 labeling requirements
- Familiarity with USFDA OTC labeling guidance and NDA/ANDA lifecycle
- Familiarity with FDA cGMP requirements
- Excellent organizational and time management skills
- Strong oral and written communication skills
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