Director, Promotional Regulatory Affairs (Immunology)

Role: Director of Promotional Regulatory Affairs responsible for shaping US regulatory strategy for pharmaceutical promotions, ensuring compliant, effective communication across multiple channels. Responsibilities include managing regulatory review processes for promotional materials, leading risk assessment and strategy development, coordinating with cross-functional teams (Medical, Legal, Commercial), providing global regulatory input, and managing FDA interactions (e.g., OPDP/APLB). The role involves training team members, enhancing review processes, monitoring regulatory trends, and representing the company as a subject matter expert. Requirements: Bachelor's in science, 3+ years in promotional regulatory affairs or FDA advertising review, with a total of 5+ years in pharma/biotech industry; strong knowledge of FDA promotional regulations and drug development/labelling. Preferred qualifications include advanced degrees in life sciences, law, or pharmacy, over 10 years’ experience in US promotional regulatory affairs, leadership in digital review platforms, and experience managing lifecycle promotion strategies across HCP, consumer, and digital media. The position demands senior-level influence, mentorship skills, and the ability to operate in a fast-paced, high-energy environment with a hybrid work setup and some onsite presence.