Job Details

Senior Manager or Associate Director, Regulatory Affairs (Advertising & Promotion)

We are seeking an experienced and detail-oriented Senior Manager or Associate Director of Regulatory Affairs (Ad Promo) to join our team. This role focuses on the regulatory review of advertising and promotional materials, especially for products related to transplant care. The ideal candidate will have deep expertise in ad-promo regulatory strategy and execution, working cross-functionally to ensure compliance with FDA regulations and internal policies.

You will report to a Director within the Regulatory Affairs team and serve as the primary contact for promotional review activities. This role has been created to support expanding business needs and ensure timely, accurate regulatory input.

Key Responsibilities:

1. Lead cross-functional promotional review teams (e.g., MLR or PRC) for transplant-related products.
2. Provide regulatory guidance and risk-based recommendations on promotional and advertising materials, including digital, print, social media, and broadcast assets.
3. Review 150–300 promotional pieces per year, ranging from 2–250 pages each, ensuring timely turnaround and compliance with FDA regulations (21 CFR Part 202.1) and OPDP guidance.
4. Interpret and apply current regulations and industry standards to support compliant promotional strategies.
5. Coordinate with Marketing, Legal, Medical Affairs, and Compliance to ensure clear messaging.
6. Prepare and submit promotional materials to OPDP as needed (Form FDA 2253).
7. Monitor the regulatory environment and assess impacts of regulatory changes on promotional practices.
8. Support training initiatives related to promotional regulatory requirements across teams.

Qualifications:

1. Bachelor's degree in a scientific, healthcare, or regulatory discipline; advanced degree preferred.
2. Minimum 7 years of regulatory experience in advertising and promotional review within the biopharmaceutical industry.
3. Strong knowledge of FDA regulations and guidance for prescription drug promotion.
4. Ability to provide clear, actionable regulatory guidance in a fast-paced environment.
5. Excellent organizational and communication skills.
6. Experience managing high-volume workloads with attention to detail.
7. Experience with transplant or specialty therapeutics is a plus.
8. Based in or willing to relocate to Cary, NC.
9. Hybrid schedule: 4 days on-site, 1 day remote weekly.

Additional Details:

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Quality Assurance
• Industries: Pharmaceutical Manufacturing and Biotechnology Research