Associate Director, Regulatory Affairs
About The Position
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? We’re looking for an Associate Director, Regulatory Affairs on the Regulatory Affairs team to help us expand what’s possible for patients with serious diseases. Reporting to the Director, Regulatory Affairs, you’ll be responsible for leading the planning, execution, and oversight of global regulatory activities supporting clinical trial applications and maintenance throughout the product development lifecycle. This role serves as the primary regulatory lead for global clinical trial submissions, ensuring timely regulatory approvals to enable clinical development across the United States, Canada, Latin America (LATAM), Asia-Pacific (APAC), and other assigned regions. You will provide regulatory leadership during agency interactions, manage regulatory questions and information requests, and coordinate cross-functional responses to facilitate timely initiation and conduct of global clinical trials.
Requirements
- Bachelor’s degree
- 5+ years of Regulatory Affairs experience in the pharmaceutical or biotechnology sector
- Direct experience with creating and managing global CTAs, CTNs, INDs, and other clinical trial authorizations
- Excellent organizational, planning, and follow-up skills.
- Ability to meet tight deadlines and be efficient, detail oriented, flexible, and a self-starter.
- Interpersonal skills to collaborate effectively across multiple functional areas
- Highly proficient with MS Office Suite programs (Word, Excel, PowerPoint, Outlook), Adobe Acrobat, and Veeva Vault
Nice To Haves
- Advance degree (PhD, PharmD, MD, MS) preferred
Responsibilities
- Ensure compliance with applicable global regulations, ICH guidelines, GCP requirements, and company procedures while driving efficient regulatory execution across multiple development programs.
- Work closely with a clinical regulatory CRO, regional regulatory experts, and company’s SMEs, develop and execute global regulatory strategies supporting Clinical Trial Applications (CTAs), INDs, Clinical Trial Notifications (CTNs), and other clinical trial authorizations across assigned regions.
- Lead regulatory planning for global clinical trial submissions, amendments, annual maintenance activities, and study closeout requirements.
- Provide regulatory guidance regarding country-specific requirements and submission pathways to support efficient clinical trial initiation.
- Assess the regulatory impact of protocol amendments and determine amendment classification (e.g., substantial vs. non-substantial amendments) in accordance with regional regulatory requirements.
- Ensure alignment of submission strategies across global regions while addressing local regulatory expectations.
- Oversee submission timelines to ensure regulatory deliverables support clinical development milestones.
- Ensure submission packages are scientifically sound, complete, and compliant with applicable regulations.
Benefits
- Comprehensive medical, dental, and vision coverage
- Mental health support
- Annual wellbeing reimbursement
- Access to our Employee Assistance Program (EAP)
- Generous paid time off policies
- Fertility and family-forming benefits
- Caregiver support
- Flexible work schedules
- 401(k) plan with a competitive company match
- Annual equity awards
- Participation in our Employee Stock Purchase Plan (ESPP)
- 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
- Meaningful opportunities to connect, volunteer, and give back
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
