Director, Regulatory Affairs (Advertising and Promotions)

Definium Therapeutics; Durham (NC); On-site; USD 180,000 - 260,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

FDA regulatory knowledge

Promotional review

Cross-functional collaboration

Veeva PromoMats

Regulatory strategy

Education

BS in science

Advanced degree preferred

Tools

Veeva PromoMats

Job description

Role

Director of Regulatory Affairs (Advertising & Promotion) overseeing FDA-regulated promotional review for biopharma products, including social media and medical communications.

Responsibilities

review and approve promotional materials and social media posts, liaise with FDA OPDP/APLB, manage regulatory interactions, ensure compliance with FDA and PhRMA guidelines, contribute to labeling strategies, and develop review processes.

Requirements

• minimum BS in science (advanced degree preferred)
• 10+ years in pharma/biotech
• at least 5 years in promotional review
• strong knowledge of FDA promotional regulations
• experience supporting CNS or psychedelics is a plus
• proficiency with Veeva PromoMats preferred

High Value

• focus on CNS/psychedelics
• regulatory review
• FDA interactions
• promotional compliance
• supporting marketed and developmental psychiatric products

Work Setup

not specified; likely office-based with potential cross-functional collaboration.