Director, Regulatory Affairs - 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 Director, Regulatory Affairs – Development Strategy on the Regulatory Affairs team to help us expand what’s possible for patients with serious diseases. Reporting to the Executive Director, Regulatory Affairs, you’ll provide strategic and operational regulatory leadership to support both business development and early-stage drug development programs and be responsible for strategic evaluation of regulatory risks and opportunities for external assets, including assessing likelihood of technical and regulatory success, and contributing to the development and execution of global regulatory strategies for internal pipeline programs. You will work cross-functionally to enable informed investment decisions and efficient advancement of development programs and develop regulatory strategy for selected drug candidates and provide regulatory input to global cross-functional project teams throughout product development and submission activities and will serve as the global or regional regulatory lead on the projects. You will act as the primary regulatory contact for the U.S. FDA.

What You'll Do:

In this role, you’ll have the opportunity to lead regulatory due diligence assessments for external assets, including evaluation of regulatory pathways, data packages, risks, and mitigation strategies. You’ll also:

• Critically assess completeness and adequacy of nonclinical, clinical, and CMC data packages, identifying key gaps, risks, and value inflection points
• Provide clear regulatory recommendations to support business development decisions and senior leadership discussions
• Contribute to cross-functional diligence teams, integrating regulatory perspectives into overall asset valuation and development planning
• Develop and support global regulatory strategies for assigned programs
• Contribute to preparation and submission of regulatory documents (e.g., pre-IND meeting requests, briefing books, INDs, amendments)
• Support health authority interactions, including meeting strategy, briefing materials, and response development
• Provide regulatory input into study design, endpoints, and overall development plans and ensure alignment of regulatory strategy with clinical, nonclinical, and CMC plans
• Partner cross-functionally with Clinical, CMC, Nonclinical, Biostatistics, and Program Management teams
• Monitor evolving regulatory landscape and apply relevant guidance and precedents and identify regulatory risks proactively and propose practical mitigation strategies
• Ensure high-quality and timely delivery of regulatory contributions across programs

Who You Are:

You have a Bachelor’s degree along with 5+ years of experience in Regulatory Affairs or related functions, with hands-on experience in regulatory submissions across multiple regions (U.S., EU, and/or other international markets). You also have:

• Experience supporting early-stage drug development (pre-IND through Phase 2)
• Demonstrated experience contributing to regulatory submissions and health authority interactions (e.g., pre-IND, Type B meetings)
• Strong understanding of global regulatory frameworks
• Deep understanding of the drug development process
• Ability to critically assess scientific, clinical, and CMC data in a regulatory context
• Strong communication, strategic thinking, and cross-functional collaboration skills
• Ability to manage multiple priorities in a fast-paced environment
• Highly organized with strong attention to detail, accuracy, clarity, and conciseness
• Ability to manage tight deadlines; must be efficient, detail-oriented, adaptable, and a self-starter

Nice to have (but not required):

• Advanced degree (PhD, PharmD, MD, MS) preferred
• Experience in regulatory due diligence, business development, or asset evaluation preferred
• Strong understanding of global regulatory frameworks (FDA, EMA; PMDA a 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 occasional domestic/international/global travel (approximately 20%)

#LI-REMOTE

#LI- JK

Pay Range:

$185,000.00-252,500.00 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.

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.

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.

For New York City Residents:

To assist in identifying candidates with qualifications matching those required and/or preferred for this role, Insmed uses an Automated Employment Decision Tool (“AEDT”) that employs artificial intelligence to analyze and score information provided in resumes and application materials including, but not limited to, skills, work experience, education, and job-related qualifications. The AEDT does not make final hiring decisions and all final hiring decisions are subject to human oversight and/or review.

If you are an applicant for this role and a New York City resident, you have the right to request:

• A reasonable accommodation, if one is available under applicable law, by emailing [email protected]; and/or

• An alternative selection process by emailing [email protected].

• Information about the type of data collected, the source of that data, and data retention practices related to the AEDT by emailing us at [email protected].