Senior 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? About the Role: We’re looking for a Senior 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 be responsible for formulating and implementing global regulatory strategies and plans to enable efficient, competitive product development for assigned programs. This role will provide regulatory input to global cross-functional project teams throughout product development and submission activities, serve as the global regulatory lead for documentation review prepared by other technical functions, and act as the primary regulatory contact for the US FDA. The role will be accountable for regulatory submissions, communications, and negotiations with global Health Authorities for designated products. What You'll Do: In this role, you’ll have the opportunity to lead development and execution of global regulatory strategies for clinical, pre-clinical, and lifecycle management activities for assigned programs. You’ll also: Identify and assess regulatory risks associated with product development and define risk-mitigation strategies Provide regulatory guidance across functions throughout the R&D process and advise on the US IND and global CTA submission strategies Direct the planning and coordination of global regulatory submissions, including clinical trial applications for multinational trials, core briefing packages, and global marketing applications Oversee the organization and preparation of clear, concise, and effective regulatory submissions Provide oversight for preparation and delivery of materials for regulatory agency meetings Prepare and deliver high-quality presentations for both internal and external audiences Monitor, evaluate, and interpret global regulatory agency activities in relevant areas; assess potential impact on company programs Lead effectively in a matrix environment, collaborating with regional regulatory leads and cross-functional teams Who You Are: You have a Bachelor’s degree in life sciences or related field along with 8 years of experience in Regulatory Affairs, with hands-on experience in regulatory submissions across multiple regions (US, EU, and/or other international markets). You are or you also have: Strong knowledge of global regulatory requirements and submission formats (eCTD) Proven experience managing complex regulatory deliverables across product lifecycle stages Strong submission writing and review skills are essential Significant experience in interactions with FDA, EMA, and other global regulatory agencies Deep understanding of the drug development process 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 Nice to have (but not required): Advanced degree (MS, PhD, PharmD) strongly preferred Experience with orphan drug products is highly preferred Experience with inhalation products a plus Where You’ll Work This 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 ... (truncated, view full listing at source)