Executive Director, Regulatory Affairs, Labeling, Advertising & Promotion
About The Position
The Executive Director, Regulatory Affairs, Labeling, Advertising & Promotion leads the strategic direction, operational performance, regulatory compliance, and organizational effectiveness of the Labeling, Advertising & Promotion unit within Insmed’s Global Regulatory Affairs department. Reporting to the SVP, Global Regulatory Affairs, this senior leader serves as the primary internal expert on relevant regulations and guides cross-functional teams from early development through commercialization. The role balances rigorous regulatory oversight with efficient, risk-based decision-making to support product launches, commercial execution, and product lifecycle management while maintaining regulatory compliance and scientific integrity. The Executive Director provides strategic leadership to the team, oversees global labeling strategy and promotional review processes, advises senior leadership, engages with health authorities, and develops the team’s capabilities and performance. This is a fully remote role that can be performed from anywhere while staying connected to the Insmed team and community. Occasional travel for team meetings or events is expected, and the role requires frequent travel of approximately 30%.
Requirements
- Bachelor’s degree in a life sciences discipline.
- 12 years of experience in pharmaceutical regulatory affairs.
- At least 6 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.
Nice To Haves
- Advanced degree (PharmD, PhD, or MS).
- Global ex-US labeling experience (EMA/EU).
Responsibilities
- Provide strategic leadership to the Labeling, Advertising & Promotion Regulatory team, establishing accountabilities, priorities, operating models, performance expectations, and cross-functional interfaces.
- Integrate labeling, advertising, and promotion activities to align approved product labeling, emerging clinical and safety information, promotional claims, and external product communications.
- Ensure labeling, advertising, and promotional communications meet applicable global regulatory requirements and scientific standards while supporting corporate objectives.
- Lead global labeling strategy, governance, lifecycle management, and implementation of product information changes across marketed and pipeline products.
- Oversee review and approval of advertising and promotional materials to ensure compliance with applicable regulations, corporate standards, and policies.
- Serve on the Global Regulatory Affairs leadership team as a strategic advisor to the SVP, Regulatory Affairs, and partner with Commercial, Marketing, Medical Affairs, Legal, Compliance, Clinical Development, Drug Safety, Quality, and other functions.
- Lead key health authority meetings and negotiations concerning labeling disputes and promotional compliance matters.
- Ensure the team has the regulatory expertise, technical capabilities, staffing, and operational capacity needed to deliver its priorities.
- Oversee resource planning, budget management, workload prioritization, and capability development; monitor performance, identify operational and compliance risks, and drive continuous improvement.
- Lead, mentor, and empower regulatory professionals overseeing labeling and advertising and promotional materials, delegating effectively to maintain focus on strategic priorities and execution.
- Develop leadership capabilities, establish succession plans, foster a high-performing culture, and define team roles, responsibilities, escalation pathways, and performance expectations.
Benefits
- Comprehensive medical, dental, and vision coverage.
- Mental health support and access to the Employee Assistance Program (EAP).
- Annual wellbeing reimbursement.
- Generous paid time off policies.
- Fertility and family-forming benefits.
- 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 with access to 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.
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What This Job Offers
Job Type
Full-time
Career Level
Executive
