Manager, Regulatory Affairs Advertising & Promotion

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. Named Science’s Top Employer in 2021, 2022, and 2023 In July 2024, we became Great Place to Work-certified in the U.S. for the fourth year in a row. Responsibilities • Represent Regulatory Affairs on Insmed’s Commercial Review Committee providing coordination and meeting facilitation • Be a member of the Commercial Review Committee (CRC) which will focus on the review and approval of typical Pharmaceutical Advertising & Promotional materials, including but not limited to, Sales Aids, Booth materials, Websites (drug specific, disease state, Corporate), commercial aspects of disease awareness, concepts reviews, commercial training modules • Facilitate, prepare and process 30 day/2253 submissions to OPDP assuring compliance and on time filing • Be in house CRC review systems expert, providing training for new users and owning system workflow processes • Reviews current policies/practices and guidelines issued by Federal regulatory agencies and update management as needed • Maintains a thorough understanding of FDA’s OPDP requirements, as well as a keen awareness of enforcement trends • Help facilitate any changes made to US Package Insert are appropriately implemented and reflected in current promotions and advertising and participate in similar assessment for ex-US labeling • Familiarity with all aspects of a Promotional Review Committee process • Must have experience interfacing with multiple departments and providing regulatory coordination • Must have expertise in FDA’s OPDP submission requirements, as well as a keen awareness of guidance/enforcement trends • Bachelor’s degree in scientific discipline; advanced degree a plus • Minimum of 1 year’s relevant work experience in Regulatory Affairs • Must have excellent communication skills (verbal and written). Insmed will not be responsible for any fees arising from the use of resumes through this source.