Regulatory Affairs Associate Director

Job Summary

To support a growing biopharmaceutical company, the remote Associate Director of Regulatory Affairs (Advertising and Promotion) will manage the review and approval of US promotional materials, medical communications, and social media postings, ensuring compliance with regulatory standards and leading interactions with the FDA.

Key responsibilities:

• Serve as the internal subject matter expert on FDA Advertising & Promotion matters for assigned products, providing regulatory advice and solutions
• Review and approve promotional and medical materials in Definium's PromoMats system, including social media posts
• Manage interactions with the FDA's OPDP/APLB, ensuring timely and accurate submissions of promotional materials

Required qualifications:

• Minimum BS in a scientific discipline; advanced degree in science preferred
• At least 8 years of experience in the pharmaceutical industry, with a minimum of 5 years in regulatory affairs
• Expert knowledge of advertising promotion regulations and FDA guidance documents
• Solid experience with promotional and medical review supporting product communications and working with the FDA
• Experience with Veeva Promomats is a strong plus