Director, Regulatory Affairs – FDA Promo & Promotion Lead

Definium Therapeutics; Durham (NC); In loco; USD 180.000 - 260.000; Tempo pieno

Descrizione del lavoro

Scorpion Therapeutics in Durham, NC, is seeking a Director of Regulatory Affairs (Advertising & Promotion) to lead FDA-regulated promotional review for biopharma products, including social media and medical communications.

The role requires 10+ years in pharma/biotech with at least 5 years in promotional review, deep knowledge of FDA promotional regulations, and preferably CNS/psychedelics experience. Veeva PromoMats proficiency is a plus, with cross-functional collaboration across teams.

Competenze

• 10+ years in pharma/biotech with regulatory experience.
• At least 5 years in promotional review.
• Strong knowledge of FDA promotional regulations.
• Experience with CNS or psychedelics a plus.

Mansioni

• Review and approve promotional materials and social media posts.
• Liaise with FDA OPDP/APLB.
• Manage regulatory interactions and ensure compliance with FDA and PhRMA guidelines.
• Contribute to labeling strategies and develop review processes.

Conoscenze

FDA regulatory knowledge

Promotional review

Cross-functional collaboration

Veeva PromoMats

Regulatory strategy

Formazione

BS in science

Advanced degree preferred

Strumenti

Veeva PromoMats

Descrizione del lavoro

Scorpion Therapeutics in Durham, NC, is seeking a Director of Regulatory Affairs (Advertising & Promotion) to lead FDA-regulated promotional review for biopharma products, including social media and medical communications.

The role requires 10+ years in pharma/biotech with at least 5 years in promotional review, deep knowledge of FDA promotional regulations, and preferably CNS/psychedelics experience. Veeva PromoMats proficiency is a plus, with cross-functional collaboration across teams.