Director, Regulatory Affairs - Development Strategy

About the role

We're seeking a Director, Regulatory Affairs – Development Strategy to join our Regulatory Affairs team. 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.

Responsibilities

• Lead regulatory due diligence assessments for external assets, including evaluation of regulatory pathways, data packages, risks, and mitigation strategies.
• 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.
• Possibly partner cross-functionally with Clinical, CMC, Nonclinical, Biostatistics, and Program Management teams.
• Maintain awareness of evolving regulatory landscape and apply relevant guidance and precedents. Identify regulatory risks proactively and propose practical mitigation strategies.
• Ensure high-quality and timely delivery of regulatory contributions across programs.

Requirements

• 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).
• Experience supporting early-stage drug development (pre-IND through Phase 2).
• Strong understanding of global regulatory frameworks.
• Deep understanding of the drug development process.
• 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.

Qualifications

• 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).

Skills

• Strong understanding of global regulatory frameworks (FDA, EMA; PMDA a plus).

Benefits

Insmed offers 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 are also available. The 401(k) plan includes a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance are offered. Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back are also provided.

Pay

$185,000.00 - $252,500.00 Annual

Schedule

This is a fully remote role. Occasional travel for team meetings or events will be expected. Travel Requirements: Approximately 20% domestic/international/global travel.