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

Insmed Incorporated•NJ Corporate Headquarters, NJ

5d•$222,000 - $303,000•Remote

About The Position

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you? About the Role: We’re looking for a Senior Director, Regulatory Affairs, Global Regulatory Lead (GRL) - Development Strategy to help us expand what’s possible for patients with serious diseases. Reporting to the Executive Director, Head of Regulatory Development Strategy, the Senior Director, RA, GRL will provide global regulatory leadership and strategic direction for assigned development programs across the product lifecycle. The GRL will be accountable for developing and driving an integrated global regulatory strategy that supports the Target Product Profile, global development plan, and business objectives while enabling efficient development, registration, and lifecycle management across major markets. As the senior regulatory representative on Global Program Teams (GPTs), the GRL will provide strategic regulatory leadership to cross-functional decision-making and ensure alignment of regulatory strategy with clinical, nonclinical, CMC, safety, commercial, and other development objectives. The GRL will work closely with regional regulatory leads in the U.S., Europe, Japan, and other relevant markets to integrate regional requirements and Health Authority perspectives into the overall global development strategy.

Requirements

An advanced degree (MS, PhD, PharmD, or equivalent) in life sciences or a related discipline and at least 10+ years of progressively responsible pharmaceutical/biotechnology regulatory affairs experience, with substantial experience supporting clinical development and global regulatory strategy.
Demonstrated experience serving as a Global Regulatory Lead or equivalent strategic regulatory leader for complex development programs.
Extensive knowledge of the global drug development and regulatory environment, with demonstrated ability to develop strategies spanning the U.S., EU, Japan, and other major international markets.
Significant experience leading interactions and negotiations with FDA, EMA, PMDA, and/or other major Health Authorities.
Demonstrated ability to translate scientific, clinical, and regulatory information into integrated global regulatory strategies and clear strategic recommendations.
Proven experience leading regulatory strategy for major submissions and managing complex regulatory programs across multiple regions and stages of the product lifecycle.
Strong understanding of clinical, nonclinical, CMC, safety, and other disciplines relevant to global drug development and their integration into regulatory strategy.
Excellent strategic thinking, judgment, negotiation, and problem-solving capabilities, with the ability to identify regulatory opportunities and develop alternative pathways when challenges arise.
Excellent written and verbal communication skills, including the ability to communicate complex regulatory issues and recommendations clearly and persuasively to senior leadership and Health Authorities.
Ability to operate effectively in a dynamic development environment, manage competing priorities, and provide strategic direction under conditions of scientific and regulatory uncertainty.

Responsibilities

Own and drive the global regulatory strategy for assigned programs, ensuring alignment with the overall product development and business strategy.
Serve as the Global Regulatory Lead and senior regulatory representative on GPTs, providing strategic regulatory guidance and influencing key development decisions, including indication strategy, development pathways, clinical program design, endpoints, patient populations, evidence requirements, and registration strategy.
Develop and maintain an integrated global regulatory strategy, incorporating U.S., EU, Japan, and other regional requirements while identifying opportunities for global alignment and efficient development.
Provide strategic leadership to regional regulatory leads, ensuring that regional strategies are aligned with the global regulatory strategy while appropriately addressing region-specific requirements.
Identify regulatory opportunities, define risks, and evaluate their impact on program objectives.
Provide strategic regulatory input into development plans, including multinational clinical trial strategies, pediatric and orphan-drug strategies, expedited development pathways, and other regulatory mechanisms where applicable.
Provide strategic review and direction for key regulatory documents and cross-functional deliverables to ensure scientific rigor, consistency with regulatory strategy, and a clear and compelling regulatory rationale.
Anticipate and interpret changes in the global regulatory environment, evolving Health Authority expectations, precedents, and competitive landscape, and translate these developments into actionable recommendations.
Communicate significant regulatory opportunities, risks, Health Authority feedback, and strategic recommendations to GPTs and senior leadership, including implications for development timelines, probability of regulatory success, and product strategy.
Provide strategic leadership in a highly matrixed global organization and mentor regulatory colleagues to strengthen regulatory strategy and organizational capabilities.

Benefits

Comprehensive medical, dental, and vision coverage and mental health support
Annual wellbeing reimbursement
Access to our Employee Assistance Program (EAP)
Generous paid time off policies
Fertility and family-forming benefits
Caregiver support
Flexible work schedules
401(k) plan with a competitive company match
Annual equity awards
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
Meaningful opportunities to connect, volunteer, and give back