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

About the role

We're seeking a Senior Director, Regulatory Affairs, Global Regulatory Lead – Development Strategy to join our Regulatory Affairs team. Reporting to the Executive Director, Regulatory Affairs, you'll develop and implement global regulatory strategies and plans for assigned programs, ensuring efficient and competitive product development.

Responsibilities

• 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.
• 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.

Requirements

• Bachelor’s degree in life sciences or related field with 8+ years of experience in Regulatory Affairs, including hands-on experience in regulatory submissions across multiple regions (US, 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 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.
• Able to manage tight deadlines; must be efficient, detail-oriented, adaptable, and a self-starter.

Qualifications

• Advanced degree (MS, PhD, PharmD) strongly preferred.
• Experience with orphan drug products is highly preferred.
• Experience with inhalation products a plus.

Benefits

Insmed offers comprehensive medical, dental, and vision coverage, mental health support, and generous paid time off policies. We also provide fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration. Additionally, we offer a 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.

Pay

$222,000.00 - $303,000.00 Annual

Schedule

This is a fully remote role. Occasional travel for team meetings or events will be expected. Travel Requirements: Approximately 20% domestic/international/global travel.