Associate Director, Regulatory Affairs - Advertising & Promotion

Associate Director, Regulatory Affairs – Advertising & Promotion The Associate Director US Regulatory Affairs - Advertising & Promotion plays a key role within the Regulatory Affairs organization and is responsible for ensuring promotional and non‑promotional materials meet the regulatory requirements with US and other health agency laws and regulations. The position provides regulatory review for promotional and medical content as part of the Promotional Review Committee (PRC) and Medical Review Committee (MRC), ensuring timely delivery of high‑quality materials and consistency across all communications.Location:Warren — New Jersey, 3 days on site & 2 days remoteSalary Range:$130k–$160kKey ResponsibilitiesParticipate in review meetings providing regulatory input on promotional and non‑promotional materials; medical materials may include medical slides, training materials, education materials, and others; promotional/marketing materials may include advertising materials, speaker training materials, commercial advisory board materials, peer‑reviewed publications and others.Collaborate with material owners, reviewers and key internal partners to ensure alignment across assigned projects/materials; key partners include Medical, Legal, Compliance, Marketing and Commercial.Represent Regulatory Affairs in functional and operational meetings as it pertains to the promotional or medical review process and best practices.Prepare and review submissions seeking regulatory advice, support the resolution of FDA action letters, and lead company interactions with FDA Office of Prescription Drug Promotion (OPDP) and other health authorities.Ensure consistency with prescribing information and safety information.Ensure standardization of defined policies, SOPs and best practices, and provide feedback and recommendations to optimize these processes and workflows.Coordinate and deliver ongoing company‑wide regulatory training related to promotional requirements for company products.Participate in training programs for internal stakeholders including specifically Medical Affairs staff to ensure best practices, up‑to‑date knowledge and operational excellence.Continuously monitor regulatory and compliance trends across the industry; analyze and interpret new regulations, guidance documents and enforcement letters. We are on a mission to advance epicutaneous immunotherapy using our innovative technology platform, Viaskin™, to develop treatment options for immunologic diseases with significant unmet medical need. That is why we are investigating a potential new class of immunotherapy, epicutaneous immunotherapy (EPIT), that aims to re‑educate the immune system of patients through the skin. Today, we are focused on exploring the use of Viaskin to address food allergies, a devastating condition that afflicts millions of patients.

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