Senior Director, Regulatory Affairs, Global Regulatory Lead - Development Strategy

Senior Director, Regulatory Affairs, Global Regulatory Lead – 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.

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

We're looking for a Senior Director, Regulatory Affairs, Global Regulatory Lead – 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. You will also 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 GRL will be accountable for regulatory submissions, communications, and negotiations with global Health Authorities for designated products.

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

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

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 Requirements

This role requires occasional domestic/international/global travel (approximately 20%)

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Pay Range:

$- 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…