Director, Regulatory Ad/Promo/Labeling
A clinical-stage biopharmaceutical company is seeking a Director, Regulatory Ad/Promo/Labeling to lead regulatory strategy across promotional materials and product labeling activities. This individual will partner closely with Commercial, Medical Affairs, Legal, and Regulatory teams to ensure communications and labeling remain compliant while supporting broader business objectives.
Key Responsibilities
- Serve as the regulatory lead for promotional review activities and provide strategic guidance on advertising, promotional, and educational materials.
- Ensure promotional content complies with applicable regulatory requirements and aligns with approved prescribing information.
- Lead interactions with regulatory agencies related to advertising and promotion activities.
- Drive labeling strategy, including the development, maintenance, and implementation of product labeling documents.
- Partner cross-functionally to support labeling negotiations, regulatory submissions, and commercialization objectives.
- Develop and maintain processes, SOPs, and compliance training programs related to Ad/Promo and labeling activities.
- Mentor and develop regulatory team members while supporting department priorities and resource planning.
Qualifications
- Bachelor's degree required; advanced degree (PharmD, PhD, MD, or equivalent) preferred.
- 8+ years of Regulatory Affairs experience within the pharmaceutical or biotechnology industry.
- Strong Ad/Promo experience, including participation in promotional review committees.
- Deep understanding of regulatory requirements governing promotional and advertising materials.
- Experience supporting product labeling strategy and lifecycle management.
- Excellent communication, stakeholder management, and organizational skills.
- Experience with Veeva PromoMats or similar promotional review systems preferred.
- Ability to travel up to 20%.
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