Senior Director - Regulatory Affairs

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 – Development Strategy on the Regulatory Affairs team to help us expand what’s possible for patients with serious diseases. Reporting to the Executive Director, Head of Regulatory Strategy and Implementation, you’ll be responsible for formulating and implementing regulatory strategies and plans to enable efficient, competitive product development for assigned programs. You will also provide regulatory input to global cross-functional project teams throughout product development and submission activities, serve as the regulatory lead for documentation review prepared by other technical functions and act as the primary regulatory contact for the US FDA. You will be accountable for regulatory submissions, communications, and negotiations with FDA for designated products.

What You'll Do:

In this role, you’ll have the opportunity to Lead development and execution of regulatory strategies for clinical, pre-clinical, and lifecycle management activities for assigned programs. You’ll also:

• Identify and assess regulatory risks associated with product development and define risk-mitigation strategies
• Provide regulatory guidance across functions throughout the R&D process and advise on the US IND, NDAs or BLAs and global CTA submission strategies
• Direct the planning and coordination of regulatory submissions, including clinical trial applications for multinational trials, core briefing packages, and global marketing applications
• Oversee the organization and preparation of clear, concise, and effective regulatory submissions
• Provide oversight for preparation and delivery of materials for regulatory agency meetings
• Prepare and deliver high-quality presentations for both internal and external audiences
• Monitor, evaluate, and interpret global regulatory agency activities in relevant areas; assess potential impact on company programs
• May lead a team of more junior employees
• Work effectively in a matrix environment, collaborating with GRL and other regulatory regional leads and cross-functional teams,

Who You Are:

You hold a Bachelor’s degree in life sciences or related field along with 8+ years of experience in Regulatory Affairs is required (advanced degree (MS, PhD, MD, PharmD) is preferred) with hands-on experience in regulatory submissions.

You are or you also have:

• Strong knowledge of global regulatory requirements and submission formats (eCTD)
• Proven experience managing complex regulatory deliverables across product lifecycle stages
• Strong submission writing and review skills are essential
• Significant experience in interactions with FDA, and other global regulatory agencies
• Deep understanding of the drug development process
• 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
• Experience with managing and mentoring other employees

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%)

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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].