Associate Director, Regulatory Affairs

About The Role

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.

Responsibilities

• 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.

Requirements

• Bachelor’s degree along with 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. Must have 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.

Qualifications

• Advance degree (PhD, PharmD, MD, MS) preferred.

Pay

$164,000.00 – $213,000.00 Annual

Schedule

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. This role requires occasional domestic/international travel (approximately 10%).

Benefits

• 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.