[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 have accountability for the strategic direction, operational performance, regulatory compliance, and organizational effectiveness for the Labeling, Advertising & Promotion unit within the Global Regulatory Affairs department.

This senior leader acts as the primary internal expert on Labeling, Advertising & Promotion regulations guiding cross-functional teams from early development through commercialization. The Executive Director will balance rigorous regulatory oversight with efficient, risk-based decision-making to support product launches, commercial execution, and product lifecycle management while maintaining the highest standards of regulatory compliance and scientific integrity.

What You'll Do

• Provide strategic leadership to the Labeling, Advertising & Promotion Regulatory team, establishing clear 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 the company’s marketed and pipeline portfolio.
• Oversee a robust review and approval process for advertising and promotional materials, ensuring compliance with applicable regulations, corporate standards, and policies while supporting business objectives.
• Serve on the Global Regulatory Affairs leadership team as a strategic advisor to the SVP, Regulatory Affairs, and a senior partner to Commercial, Marketing, Medical Affairs, Legal, Compliance, Clinical Development, Drug Safety, Quality, and other relevant functions.
• Lead key health authority meetings and negotiations on labeling disputes and promotional compliance matters.
• Ensure the team has the regulatory expertise, technical capabilities, staffing, and operational capacity to deliver on 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, and foster a high-performing culture; define team roles, responsibilities, escalation pathways, and performance expectations.

Qualifications

• Bachelor’s degree in a life sciences discipline.
• 12 years of experience in pharmaceutical regulatory affairs, including 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.

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.

Company 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.