[Hiring] Executive Director, Regulatory Affairs, Labeling, Advertising & Promotion @Insmed Incorporated

Role Description

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.

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.

Qualifications

• Bachelor’s degree in a life sciences discipline.
• 15 years of experience in pharmaceutical regulatory affairs, including 8+ years focused specifically on labeling and advertising/promotional compliance.
• 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.

Requirements

• An advanced degree (PharmD, PhD, or MS) is preferred.
• Global ex-US labeling experience (EMA/EU) is a strong plus.

Benefits

• Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP).
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration.
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance.
• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities.
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back.