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

Insmed Incorporated

85d • $215,000 - $301,000

About The Position

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.

Requirements

• 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

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

Benefits

• 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
• 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)
• Company-paid life and disability insurance
• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

What This Job Offers

• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree