Director, Regulatory Affairs - Development Strategy

Director, Regulatory Affairs – Development Strategy

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 a Director, Regulatory Affairs – Development Strategy on the Regulatory Affairs team to help us expand what's possible for patients with serious diseases. 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 and be responsible for strategic evaluation of regulatory risks and opportunities for external assets, including assessing likelihood of technical and regulatory success, and contributing to the development and execution of global regulatory strategies for internal pipeline programs.

You will work cross-functionally to enable informed investment decisions and efficient advancement of development programs and develop regulatory strategy for selected drug candidates and provide regulatory input to global cross-functional project teams throughout product development and submission activities and will serve as the global or regional regulatory lead on the projects. You will act as the primary regulatory contact for the U.S. FDA.

In this role, you'll have the opportunity to lead regulatory due diligence assessments for external assets, including evaluation of regulatory pathways, data packages, risks, and mitigation strategies. You'll also:

• 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
• Partner cross-functionally with Clinical, CMC, Nonclinical, Biostatistics, and Program Management teams
• Monitor evolving regulatory landscape and apply relevant guidance and precedents and identify regulatory risks proactively and propose practical mitigation strategies
• Ensure high-quality and timely delivery of regulatory contributions across programs

You have 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). You also have:

• Experience supporting early-stage drug development (pre-IND through Phase
  2)
• Demonstrated experience contributing to regulatory submissions and health authority interactions (e.g., pre-IND, Type B meetings)
• Strong understanding of global regulatory frameworks
• Deep understanding of the drug development process
• Ability to critically assess scientific, clinical, and CMC data in a regulatory context
• 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,…