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

Role Summary

Sr. Director, Regulatory Affairs, Global Regulatory Lead - Development Strategy at Insmed. Lead development and execution of global regulatory strategies for clinical, pre-clinical, and lifecycle management activities for assigned programs; serve as primary regulatory contact for global Health Authorities and oversee regulatory submissions and communications.

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
• 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

Qualifications

• Bachelor‚Äôs 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

Skills

• Global regulatory strategy development
• Regulatory submissions management (eCTD)
• Regulatory intelligence and risk assessment
• Cross-functional collaboration in R&D
• Executive-level communication and presentation

Education

• Bachelor‚Äôs degree in life sciences or related field; advanced degree preferred