Sr. Director, Regulatory Affairs, Global Regulatory Lead - Development Strategy at Insmed in Corporate Headquarters, NJ

Job description

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? About the Role: 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: In this role, you'll have the opportunity to lead regulatory strategy for interactions and negotiations with FDA, EMA, PMDA, and other Health Authorities and will be accountable for the strategic content, positioning, and regulatory objectives of major global submissions and Health Authority engagements. You'll also: 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, including indication strategy, development pathways, clinical program design, endpoints, patient populations, evidence requirements, and registration strategy. Develop and maintain an integrated global regulatory strategy, incorporating U.S., EU, Japan, and other regional requirements while identifying opportunities for global alignment and efficient development. Provide strategic leadership to regional regulatory leads, ensuring that regional strategies are aligned with the global regulatory strategy while appropriately addressing region-specific requirements. Identify regulatory opportunities, define risks, and evaluate their impact on program objectives. Provide strategic regulatory input into development plans, including multinational clinical trial strategies, pediatric and orphan-drug strategies, expedited development pathways, and other regulatory mechanisms where applicable. Provide strategic review and direction for key regulatory documents and cross-functional deliverables to ensure scientific rigor, consistency with regulatory strategy, and a clear and compelling regulatory rationale. Anticipate and interpret changes in the global regulatory environment, evolving Health Authority expectations, precedents, and competitive landscape, and translate these developments into actionable recommendations. Communicate significant regulatory opportunities, risks, Health Authority feedback, and strategic recommendation