[Hiring] Senior Director, Regulatory Affairs, Global Regulatory Lead - Development Strategy @Insmed Incorporated

Role Description

We’re looking for a Senior Director, Regulatory Affairs, Global Regulatory Lead (GRL) - Development Strategy to help us expand what’s possible for patients with serious diseases. Reporting to the Executive Director, Head of Regulatory Development Strategy, the Senior Director, RA, GRL will provide global regulatory leadership and strategic direction for assigned development programs across the product lifecycle.

The GRL will be accountable for developing and driving an integrated global regulatory strategy that supports the Target Product Profile, global development plan, and business objectives while enabling efficient development, registration, and lifecycle management across major markets. As the senior regulatory representative on Global Program Teams (GPTs), the GRL will provide strategic regulatory leadership to cross-functional decision-making and ensure alignment of regulatory strategy with clinical, nonclinical, CMC, safety, commercial, and other development objectives. The GRL will work closely with regional regulatory leads in the U.S., Europe, Japan, and other relevant markets to integrate regional requirements and Health Authority perspectives into the overall global development strategy.

What You'll Do

• Lead regulatory strategy for interactions and negotiations with FDA, EMA, PMDA, and other Health Authorities.
• Own and drive the global regulatory strategy for assigned programs, ensuring alignment with the overall product development and business strategy.
• Serve as the Global Regulatory Lead and senior regulatory representative on GPTs, providing strategic regulatory guidance and influencing key development decisions.
• Develop and maintain an integrated global regulatory strategy, incorporating U.S., EU, Japan, and other regional requirements.
• Provide strategic leadership to regional regulatory leads, ensuring alignment with the global regulatory strategy.
• Identify regulatory opportunities, define risks, and evaluate their impact on program objectives.
• Provide strategic regulatory input into development plans, including multinational clinical trial strategies and expedited development pathways.
• Provide strategic review and direction for key regulatory documents and cross-functional deliverables.
• Anticipate and interpret changes in the global regulatory environment and translate these developments into actionable recommendations.
• Communicate significant regulatory opportunities, risks, and strategic recommendations to GPTs and senior leadership.
• Provide strategic leadership in a highly matrixed global organization and mentor regulatory colleagues.

Qualifications

• Advanced degree (MS, PhD, PharmD, or equivalent) in life sciences or a related discipline.
• At least 10+ years of progressively responsible pharmaceutical/biotechnology regulatory affairs experience.
• Demonstrated experience serving as a Global Regulatory Lead or equivalent strategic regulatory leader.
• Extensive knowledge of the global drug development and regulatory environment.
• Significant experience leading interactions and negotiations with FDA, EMA, PMDA, and/or other major Health Authorities.
• Demonstrated ability to translate scientific, clinical, and regulatory information into integrated global regulatory strategies.
• Proven experience leading regulatory strategy for major submissions and managing complex regulatory programs.
• Strong understanding of clinical, nonclinical, CMC, safety, and other disciplines relevant to global drug development.
• Excellent strategic thinking, judgment, negotiation, and problem-solving capabilities.
• Excellent written and verbal communication skills.
• Ability to operate effectively in a dynamic development environment.

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, and caregiver support.
• Flexible work schedules with purposeful in-person collaboration.
• 401(k) plan with a competitive company match and annual equity awards.
• Participation in our Employee Stock Purchase Plan (ESPP) and company-paid life and disability insurance.
• Company Learning Institute providing access to LinkedIn Learning and skill-building workshops.
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect and volunteer.

Travel Requirements

• This role requires occasional domestic/international/global travel (approximately 20%).