Director, Regulatory Ad/Promo
A leading biopharma is seeking a seasoned regulatory professional to join its Regulatory Affairs Advertising and Promotional team. This role will provide strategic leadership in the review of promotional materials and oversee regulatory aspects of internal and external communications, including advertising and promotional activities in the U.S.
The Director will serve as a key advisor on promotional and non-promotional programs for oncology or other therapeutic areas, ensuring compliance with FDA regulations while supporting business objectives. This position requires strong collaboration with cross-functional partners in Regulatory, Medical, Legal/Compliance, and Commercial teams.
Key Responsibilities
- Lead the Promotional Material Review Committee (PMRC) for assigned products in the U.S.
- Provide regulatory guidance on concepts and draft promotional materials to meet FDA requirements and corporate standards.
- Act as the regulatory lead for new product launches, contributing to U.S. launch planning and execution.
- Manage regulatory aspects of promotional material review and approval, including timely submission to the FDA's Office of Prescription Drug Promotion (OPDP).
- Partner with Medical Affairs, Legal/Compliance, Marketing, and other teams to ensure efficient review processes.
- Lead interactions with FDA/OPDP for assigned products, including advisory comment submissions.
- Stay current on evolving FDA regulations, enforcement trends, and policy changes, and communicate implications to stakeholders.
Qualifications
- Minimum 8 years of pharmaceutical industry experience, including at least 5 years in regulatory affairs focused on advertising and promotion.
- Experience in oncology and new product launches strongly preferred.
- In-depth knowledge of FDA regulations and guidelines related to promotional activities.
- Strong decision-making, collaboration, and communication skills.
- Bachelor's degree in a scientific discipline required; advanced degree (e.g., PharmD) strongly preferred.
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