Executive Director, Regulatory Affairs, Labeling, Advertising & Promotion at Insmed in Corporate Headquarters, NJ

Job description

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you? About the Role: We're looking for an Executive Director, Regulatory Affairs, Labeling, Advertising & Promotion to help us expand what's possible for patients with serious diseases. Reporting to the SVP, Global Regulatory Affairs, the Executive Director will lead both the labeling and advertising & promotion strategy for all programs and products. This senior leader acts as the primary internal expert on Labeling, Advertising & Promotion regulations guiding cross-functional teams from early development through commercialization. This individual will direct a team that creates compliant product labels and promotional materials and will have direct communication with health authorities. What You'll Do: In this role, you’ll have the opportunity to direct the global labeling strategy for clinical development programs and approved commercial products while developing and implementing promotional regulatory strategies for commercialized programs. You'll also: Mentor and direct a team of regulatory professionals responsible for creation and maintenance of labeling and advertising/promotional materials, delegating tasks effectively and appropriately to direct focus on strategic planning and execution. Oversee Labeling: Direct the creation, updates, and maintenance of Company Core Data Sheets (CCDS), US Prescribing Information (USPI), ex-US regional labeling components (EU SmPC), and Patient Information. Ensure product labels comply with FDA, EMA, and regional health authority regulations. Participate in labeling negotiations with agencies resulting in product approvals or labeling updates. Support audits and CAPA resolutions and represent labeling on cross-functional leadership programs and advisory boards Drive Advertising and Promotion: Propose creative, effective, and compliant regulatory strategies and solutions to challenging promotional concepts that meet business objectives and minimize risk Provide promotional regulatory input on concepts and draft materials to ensure they are aligned with promotional regulations, corporate standards and policies and business objectives Serve as the subject matter expert, partnering with cross functional teams to ensure messaging aligns with Health Authority regulations and company objectives Lead major meetings and negotiations with health authorities regarding labeling disputes or promotional compliance. Evaluate regulatory risks in marketing campaigns and labeling changes; provide clear solutions to cross-functional teams. Partner with launch team, commercial, medical affairs, clinical development, corporate communications, and legal. Who You Are: You must have a Bachelor’s degree in a life sciences discipline and 15 years of experience in pharmaceutical regulatory affairs, including 8+ years focused specifically on labeling and advertising/promotional compliance. Additionally, you have: Proven experience managing high-performing regulatory teams and working with senior executives. Expert understanding of FDA regulations, guidance documents, and promotional enforcement actions (such as Untitled and Warning Letters). Exceptional writing, negotiation, and public-speaking skills. Nice to Have (but not required): An advanced degree (PharmD, PhD, or MS) is preferred. Global ex-US labeling experience (EMA/EU) is a strong plus. Where Yo