Associate Director, Regulatory Affairs Advertising & Promotion Compliance

Education

Bachelor’s degree in life science or closely related discipline. Advance degree preferred (Pharm.D., Phd, M.S, JD)

Experience

•    Minimum five (7) years of progressive experience in the pharmaceutical or biotechnology industry, specifically in Regulatory Affairs with a focus on Advertising and Promotion (Ad/Promo).

•    Proven track record as the primary regulatory reviewer for promotional and non-promotional materials across various therapeutic areas, ensuring compliance with FDA regulations, industry guidelines (e.g., OPDP, PhRMA), and internal policies.

•    Strong experience in leading and managing Regulatory review processes within cross-functional Medical, Legal, and Regulatory (MLR) teams for both consumer and professional marketing materials.

•    The Associate Director is responsible for providing strategic and tactical regulatory support and guidance for assigned product and disease state communications as well as pipeline and non-promotional communications.

•    Provides guidance and input for assigned development products reflective of promotional considerations, including assessment of potential labeling claims.

•    Serves as Promotional Review Committee (PRC) chair and as the primary regulatory reviewer of advertising, promotions, and other related materials for assigned product to ensure compliance with applicable FDA/Health Canada laws, regulations, and guidance.

•    Works collaboratively with cross-functional partners, including Legal and Medical as part of PRC. Develops solutions to complex promotional issues by utilizing scientific and regulatory knowledge to support business objectives and initiatives while effectively identifying, escalating, and managing business risks.

•    Serves as the regulatory reviewer for the Medical Review Process (MRC) for assigned product(s).

•    Provides direction and works collaboratively to ensure that changes in US Prescribing Information and Canadian Product Monograph are reflected in current promotions and advertising