Executive Director, Regulatory Affairs, Labeling, Advertising & Promotion

Compensation

$255,000.00 - $255,000.00 / Yearly

Hours Per Week

40

Number Of Positions

1

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 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:

In this role, you'll have the opportunity to provide strategic leadership to the Labeling, Advertising & Promotion Regulatory team, establishing clear accountabilities, priorities, operating models, performance expectations, and cross-functional interfaces. You'll also:

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.

Who You Are:

You must have aBachelor's degree in a life sciences discipline and 12 years of experience in pharmaceutical regulatory affairs, including at least 6 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 You'll Work

This is a fully remote role. It can be performed effectively from anywhere while staying connected to your Insmed team and community. Occasional travel for team meetings or events will be expected.

Travel Requirements

This role requires frequent travel (approximately 30%).

#LI-Remote

#LI-MM1

Pay Range:

$255,000.00-347,500.00 Annual

Life at Insmed

At Insmed, you'll find a culture as human as our mission-intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.

Highlights of our U.S. offerings include:

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

Eligibility for specific programs may vary and is subject to the terms and conditions of each plan.

Current Insmed Employees: Please apply via the Jobs Hub in Workday.

Insmed Incorporated is an Equal Opportunity employer. We do not discriminate in hiring on the basis of physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. For more information, please refer to our Equal Employment Opportunity and Non-Discrimination Statement on our Careers site.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Insmed is committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, its services, programs, and activities. To request reasonable accommodation to participate in the job application or interview process, please contact us by email at [email protected] and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

Applications are accepted for 5 calendar days from the date posted or until the position is filled.

Important Notice for Job Seekers: Insmed will only communicate with candidates from an @insmed.com email address and will never request payment of any kind during the hiring process. If you'd like guidance on recognizing potential recruitment fraud, please reach out to [email protected] .

Apply here: https://www.aplitrak.com/?adid=YmJnZW5lcmljLjM5MjY0LjEwNDEyQGluc21lZGNvbXAuYXBsaXRyYWsuY29t

Place of Work

On-site

Requisition ID

R3868-3486