Senior Director, Regulatory Affairs

Insmed Incorporated•NJ Corporate Headquarters, NJ

1d•$222,000 - $303,000•Remote

About The Position

Insmed is seeking a Senior Director, Regulatory Affairs, Global Regulatory Lead – Development Strategy, on its Regulatory Affairs team. Reporting to the Executive Director, Head of Regulatory Strategy and Implementation, this role formulates and implements regulatory strategies and plans to support efficient, competitive product development for assigned programs. The position provides regulatory input to global cross-functional project teams throughout product development and submission activities, leads regulatory review of documentation prepared by other technical functions, and serves as the primary regulatory contact for the US FDA. The role is accountable for regulatory submissions, communications, and negotiations with FDA for designated products. It may lead more junior employees and requires collaboration in a matrix environment. This is a fully remote role with approximately 20% occasional domestic, international, or global travel.

Requirements

Bachelor’s degree in life sciences or a related field.
At least 8 years of experience in Regulatory Affairs.
Hands-on experience in regulatory submissions.
Strong knowledge of global regulatory requirements and submission formats, including eCTD.
Proven experience managing complex regulatory deliverables across product lifecycle stages.
Strong submission writing and review skills.
Significant experience interacting with FDA and other global regulatory agencies.
Deep understanding of the drug development process.
Strong organization and attention to detail, accuracy, clarity, and conciseness.
Ability to manage tight deadlines; efficiency, adaptability, and self-direction.
Experience managing and mentoring other employees.

Nice To Haves

Advanced degree (MS, PhD, MD, or PharmD).

Responsibilities

Lead development and execution of 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 US IND, NDA, or BLA and global CTA submission strategies.
Direct 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 internal and external audiences.
Monitor, evaluate, and interpret global regulatory agency activities in relevant areas and assess their potential impact on company programs.
Serve as regulatory lead for review of documentation prepared by other technical functions and as primary regulatory contact for the US FDA.
Manage regulatory submissions, communications, and negotiations with FDA for designated products.
Collaborate effectively in a matrix environment with GRL and other regional regulatory leads and cross-functional teams.
May lead a team of more junior employees.

Benefits

Comprehensive medical, dental, and vision coverage
Mental health support
Annual wellbeing reimbursement
Access to Employee Assistance Program (EAP)
Generous paid time off policies
Fertility and family-forming benefits
Caregiver support
Flexible work schedules
401(k) plan with competitive company match
Annual equity awards
Employee Stock Purchase Plan (ESPP)
Company-paid life and disability insurance
Company Learning Institute with LinkedIn Learning, skill-building workshops, leadership programs, mentorship connections, and networking opportunities
Employee resource groups
Service and recognition programs
Opportunities to connect, volunteer, and give back