Associate Director, US Advertising & Promotion Regulatory Review

You will be a key member of the US Medical team, serving as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. Responsibilities • Serve as an internal expert on FDA regulations governing prescription drug and biologic product promotion • Provide regulatory oversight for complex products to ensure compliance of promotional materials • Mentor and develop staff, providing technical and regulatory guidance • Chair promotional review meetings and assist in planning promotional materials • Collaborate with cross-functional teams to execute and approve key Commercial campaigns • Review and assess proposed promotional items for compliance with regulatory requirements • Identify regulatory issues and propose creative solutions and risk mitigation strategies • Present insights from FDA advisory comments and enforcement actions to senior management • Act as a primary liaison with OPDP and APLB reviewers regarding claims and promotional strategies Qualifications • Bachelor’s Degree in life science or equivalent required; advanced degree (PharmD, PhD, MS, MBA, JD) preferred • Minimum of 5 years’ experience in drug, biologic, and/or device Regulatory Affairs • At least 3 years’ experience specific to Regulatory Affairs – Advertising and Promotion • Knowledge of regulations specific to advertising and promotion of pharmaceutical products • Experience managing major regulatory filings and providing guidance to drug development teams • Regulatory Affairs Certification (RAC) desirable Experience Requirements • Minimum of 5 years in Regulatory Affairs or related field • At least 3 years in Advertising and Promotion regulatory experience • Experience with regulatory guidance and compliance processes Why work in Lexington, MA

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