Senior Director, Regulatory Affairs

About the Role

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, Head of Regulatory Strategy and Implementation, you'll be responsible for formulating and implementing 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 regulatory lead for documentation review prepared by other technical functions and act as the primary regulatory contact for the US FDA. You will be accountable for regulatory submissions, communications, and negotiations with FDA for designated products.

What You'll Do

In this role, you'll have the opportunity to lead development and execution of 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, NDAs or BLAs and global CTA submission strategies
• Direct the planning and coordination of 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
• May lead a team of more junior employees
• Work effectively in a matrix environment, collaborating with GRL and other regulatory regional leads and cross-functional teams

Who You Are

You hold a Bachelor's degree in life sciences or related field along with 8+ years of experience in Regulatory Affairs is required (advanced degree (MS, PhD, MD, PharmD) is preferred) with hands-on experience in regulatory submissions. 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, 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
• Experience with managing and mentoring other employees

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