Associate Director/ Director, Regulatory Affairs (Global Regulatory Advertising and Promotion)

RoleAssociate Director of Regulatory Affairs for Advertising and Promotion, focusing on US prescription drug promotional materials. Responsibilitiesprovide strategic regulatory review and guidance across multiple channels (digital, print, speaker programs, congresses) lead or support US promotional review committees (MLR) manage FDA submissions (FDA 2253) monitor industry enforcement trends support product launch activities develop internal policies and SOPs mentor junior staff collaborate cross-functionally to ensure compliant, effective promotional strategies RequirementsBachelor's in life sciences or related field 7+ years in Regulatory Affairs Advertising & Promotion within pharma/biotech strong knowledge of FDA-OPDP regulations, MLR processes experience with US promotional material review and FDA submissions familiarity with review systems like Veeva PromoMats Preferredproduct launch experience background in specialty, rare disease, oncology global promotional regulatory experience fast-paced biotech environment High-ValueUS prescription drug promotion, FDA regulatory oversight, cross-functional coordination, digital and multi-channel marketing, product launch support Work Setupnot specified.