Sr. Director, Regulatory Affairs, Global Regulatory Lead - Development Strategy

Join Insmed

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.

For patients, for each other, and for the future of science, we're in. Are you?

About the Role : The Global Regulatory Lead (GRL)

The Global Regulatory Lead (GRL) will 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. The GRL will serve as the global regulatory lead for documentation review prepared by other technical functions and will act as the primary regulatory contact for the U.S. FDA. The GRL will be accountable for regulatory submissions, communications, and negotiations with global health authorities for designated products.

What You'll Do :

Lead development and execution of global regulatory strategies for clinical, pre-clinical, and lifecycle management activities for assigned programs. 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 :

Bachelor's degree in life sciences or a related field required; advanced degree (MS, PhD, PharmD) strongly preferred. Minimum of 5 years of experience in Regulatory Affairs, with hands-on experience in regulatory submissions across multiple regions (U.S., EU, and / or other international markets). 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 essential. Experience with orphan drug products is highly preferred. Experience with inhalation products a plus. 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.

Pay Range : $215,000.00-301,000.00 Annual

Life at Insmed

At 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 collaboration. 401(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 insurance. Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities.