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Director, Commercial Regulatory Affairs
162173
Posted:
18/03/2025
- Competitive
- Cambridge, United States
- Permanent
MEET have partnered with one of our top global biotech clients focused in the oncology, rare disease and neuroscience space to bring on an Director Commercial Regulatory Affairs to their wonderful team. Based in Cambridge, MA, they are looking at a hybrid model.
Responsibilities:
Knowledge & Experience:
Responsibilities:
- Serve as the internal expert on FDA Advertising & Promotion for assigned products, providing regulatory advice and resolving comments on promotional materials.
- Provide regulatory training on FDA requirements, PhRMA DTC Guidelines, and company policies. Lead Promotional Review Committees (PRC) to ensure compliance.
- Develop SOPs and work instructions to streamline workflows and improve process efficiency.
- Act as the primary contact with FDA/OPDP on advertising and promotional matters, managing submissions and responses.
- Foster a collaborative partnership between Regulatory and PRC teams to support compliant marketing execution.
- Lead PRC teams in managing tasks like implementing revised product labels and training materials.
- May manage junior staff.
Knowledge & Experience:
- BS in a scientific discipline.
- Minimum 7 years in the pharmaceutical industry, with 6+ years in regulatory affairs.
- Experience in Rare Diseases, Neuroscience, and/or Oncology is a plus.
- Expert knowledge of FDA advertising and promotion regulations and experience with OPDP/APLB submissions.
Kaitlyn Sumner
Account Manager