Executive Director, Regulatory Affairs, Labeling, Advertising & Promotion
About The Position
Insmed is seeking an Executive Director to lead global labeling and advertising and promotion strategy for its programs and products. Reporting to the SVP, Global Regulatory Affairs, this senior leader will serve as the primary internal expert on labeling and promotional regulations, guiding cross-functional teams from early development through commercialization. The role directs a team that creates compliant product labeling and promotional materials and includes direct communication with health authorities. The Executive Director will direct labeling strategies for clinical development programs and approved commercial products, and develop and implement promotional regulatory strategies for commercialized programs. Responsibilities include leading labeling creation and maintenance, supporting agency negotiations and audits, providing regulatory guidance on promotional materials and marketing campaigns, evaluating risk, and partnering with teams across the company. The role is fully remote, with occasional travel for team meetings or events and approximately 10% domestic travel.
Requirements
- Bachelor’s degree in a life sciences discipline.
- 15 years of experience in pharmaceutical regulatory affairs, including 8 or more years specifically focused 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, including Untitled and Warning Letters.
- Exceptional writing, negotiation, and public-speaking skills.
Nice To Haves
- Advanced degree such as a PharmD, PhD, or MS.
- Global ex-US labeling experience, including EMA/EU.
Responsibilities
- Direct global labeling strategy for clinical development programs and approved commercial products.
- Develop and implement promotional regulatory strategies for commercialized programs.
- Mentor and direct a team responsible for creating and maintaining labeling and advertising/promotional materials; delegate work to support strategic planning and execution.
- Direct the creation, updating, and maintenance of Company Core Data Sheets (CCDS), US Prescribing Information (USPI), ex-US regional labeling components such as EU SmPC, and Patient Information.
- Ensure product labels comply with FDA, EMA, and regional health authority regulations.
- Participate in labeling negotiations with agencies related to product approvals or labeling updates.
- Support audits and CAPA resolutions, and represent labeling on cross-functional leadership programs and advisory boards.
- Propose effective, compliant regulatory strategies and solutions for challenging promotional concepts while meeting business objectives and minimizing risk.
- Provide promotional regulatory input on concepts and draft materials to align them with promotional regulations, corporate standards, policies, and business objectives.
- Serve as a subject matter expert and partner with cross-functional teams to align messaging 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 and provide solutions to cross-functional teams.
- Partner with launch, commercial, medical affairs, clinical development, corporate communications, and legal teams.
Benefits
- Comprehensive medical, dental, and vision coverage.
- Mental health support and access to an Employee Assistance Program (EAP).
- Annual wellbeing reimbursement.
- Generous paid time off policies.
- Fertility and family-forming benefits and caregiver support.
- Flexible work schedules with purposeful in-person collaboration.
- 401(k) plan with a competitive company match.
- Annual equity awards.
- Participation in the Employee Stock Purchase Plan (ESPP).
- Company-paid life and disability insurance.
- Company Learning Institute, including LinkedIn Learning, skill-building workshops, leadership programs, mentorship connections, and networking opportunities.
- Employee resource groups, service and recognition programs, and opportunities to connect, volunteer, and give back. Eligibility for specific programs may vary and is subject to plan terms and conditions.
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What This Job Offers
Job Type
Full-time
Career Level
Executive
