Senior Director, Regulatory Affairs, Global Regulatory Lead - Development Strategy

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 a Senior Director, Regulatory Affairs, Global Regulatory Lead (GRL) - Development Strategy to help us expand what’s possible for patients with serious diseases. Reporting to the Executive Director, Head of Regulatory Development Strategy, the Senior Director, RA, GRL will provide global regulatory leadership and strategic direction for assigned development programs across the product lifecycle.

The GRL will be accountable for developing and driving an integrated global regulatory strategy that supports the Target Product Profile, global development plan, and business objectives while enabling efficient development, registration, and lifecycle management across major markets. As the senior regulatory representative on Global Program Teams (GPTs), the GRL will provide strategic regulatory leadership to cross-functional decision-making and ensure alignment of regulatory strategy with clinical, nonclinical, CMC, safety, commercial, and other development objectives. The GRL will work closely with regional regulatory leads in the U.S., Europe, Japan, and other relevant markets to integrate regional requirements and Health Authority perspectives into the overall global development strategy.

What You'll Do:

In this role, you'll have the opportunity to lead regulatory strategy for interactions and negotiations with FDA, EMA, PMDA, and other Health Authorities and will be accountable for the strategic content, positioning, and regulatory objectives of major global submissions and Health Authority engagements. You'll also:

• Own and drive the global regulatory strategy for assigned programs, ensuring alignment with the overall product development and business strategy.
• Serve as the Global Regulatory Lead and senior regulatory representative on GPTs, providing strategic regulatory guidance and influencing key development decisions, including indication strategy, development pathways, clinical program design, endpoints, patient populations, evidence requirements, and registration strategy.
• Develop and maintain an integrated global regulatory strategy, incorporating U.S., EU, Japan, and other regional requirements while identifying opportunities for global alignment and efficient development.
• Provide strategic leadership to regional regulatory leads, ensuring that regional strategies are aligned with the global regulatory strategy while appropriately addressing region-specific requirements.
• Identify regulatory opportunities, define risks, and evaluate their impact on program objectives.
• Provide strategic regulatory input into development plans, including multinational clinical trial strategies, pediatric and orphan-drug strategies, expedited development pathways, and other regulatory mechanisms where applicable.
• Provide strategic review and direction for key regulatory documents and cross-functional deliverables to ensure scientific rigor, consistency with regulatory strategy, and a clear and compelling regulatory rationale.
• Anticipate and interpret changes in the global regulatory environment, evolving Health Authority expectations, precedents, and competitive landscape, and translate these developments into actionable recommendations.
• Communicate significant regulatory opportunities, risks, Health Authority feedback, and strategic recommendations to GPTs and senior leadership, including implications for development timelines, probability of regulatory success, and product strategy.
• Provide strategic leadership in a highly matrixed global organization and mentor regulatory colleagues to strengthen regulatory strategy and organizational capabilities.

Who You Are:

You have an advanced degree (MS, PhD, PharmD, or equivalent) in life sciences or a related discipline and at least 10+ years of progressively responsible pharmaceutical/biotechnology regulatory affairs experience, with substantial experience supporting clinical development and global regulatory strategy.

Additionally, you have:

• Demonstrated experience serving as a Global Regulatory Lead or equivalent strategic regulatory leader for complex development programs.
• Extensive knowledge of the global drug development and regulatory environment, with demonstrated ability to develop strategies spanning the U.S., EU, Japan, and other major international markets.
• Significant experience leading interactions and negotiations with FDA, EMA, PMDA, and/or other major Health Authorities.
• Demonstrated ability to translate scientific, clinical, and regulatory information into integrated global regulatory strategies and clear strategic recommendations.
• Proven experience leading regulatory strategy for major submissions and managing complex regulatory programs across multiple regions and stages of the product lifecycle.
• Strong understanding of clinical, nonclinical, CMC, safety, and other disciplines relevant to global drug development and their integration into regulatory strategy.
• Excellent strategic thinking, judgment, negotiation, and problem-solving capabilities, with the ability to identify regulatory opportunities and develop alternative pathways when challenges arise.
• Excellent written and verbal communication skills, including the ability to communicate complex regulatory issues and recommendations clearly and persuasively to senior leadership and Health Authorities.
• Ability to operate effectively in a dynamic development environment, manage competing priorities, and provide strategic direction under conditions of scientific and regulatory uncertainty.

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 occasional domestic/international/global travel (approximately 20%).

#LI-TB1

#LI-Remote

Pay Range:

$222,000.00-303,000.00 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].