About the Role: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.What You'll Do:Critically assess completeness and adequacy of nonclinical, clinical, and CMC data packages, identifying key gaps, risks, and value inflection pointsProvide clear regulatory recommendations to support business development decisions and senior leadership discussionsContribute to cross-functional diligence teams, integrating regulatory perspectives into overall asset valuation and development planningDevelop and support global regulatory strategies for assigned programsContribute 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 developmentProvide regulatory input into study design, endpoints, and overall development plans and ensure alignment of regulatory strategy with clinical, nonclinical, and CMC plansPartner cross-functionally with Clinical, CMC, Nonclinical, Biostatistics, and Program Management teamsMonitor evolving regulatory landscape and apply relevant guidance and precedents and identify regulatory risks proactively and propose practical mitigation strategiesEnsure high-quality and timely delivery of regulatory contributions across programsWho You Are:You have a Bachelor’s degree along with 5+ years of experience h 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 frameworksDeep understanding of the drug development processAbility to critically assess scientific, clinical, and CMC data in a regulatory contextStrong communication, strategic thinking, and cross-functional collaboration skillsAbility to manage multiple priorities in a fast-paced environmentHighly organized with strong attention to detail, accuracy, clarity, and concisenessAbility to manage tight deadlines; must be efficient, detail-oriented, adaptable, and a self-starterNice to have (but not required):Advanced degree (PhD, PharmD, MD, MS) preferredExperience iness development, or asset evaluation preferredStrong understanding of global regulatory frameworks (FDA, EMA; PMDA a plus)Where You’ll WorkThis 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.Travel RequirementsThis role requires occasional domestic/international/global travel (approximately 20%)Life at InsmedAt Insmed, you’ll find a culture as human as our mission—intentionally designed for the people behind it. You deserve a workplace that reflects the same care you bring to your work each day, with support for how you work, how you grow, and how you show up for patients, your team, and yourself.Highlights of our U.S. offerings include: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 collaboration401(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 insuranceCompany Learning Institute providing access to Linkedll building workshops, leadership programs, mentorship connections, and networking opportunitiesEmployee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give backEligibility for specific programs may vary and is subject to the terms and conditions of each plan.
about 1 month ago