Director, Regulatory Affairs - Development Strategy

Role Overview

We're looking for a Director, Regulatory Affairs – Development Strategy on the Regulatory Affairs team to help us expand what's possible for patients with serious diseases. Reporting to the Executive Director, Regulatory Affairs, you'll provide strategic and operational regulatory leadership to support both business development and early-stage drug development programs.

What You Will Do

In this role, you'll have the opportunity to lead regulatory due diligence assessments for external assets, including evaluation of regulatory pathways, data packages, risks, and mitigation strategies. You'll also critically assess completeness and adequacy of nonclinical, clinical, and CMC data packages, identifying key gaps, risks, and value inflection points.

Why It Might Be a Fit

You have a Bachelor’s degree along with 5+ years of experience in Regulatory Affairs or related functions, with hands-on experience in regulatory submissions across multiple regions (U.S., EU, and/or other international markets).

Requirements

• Bachelor’s degree
• 5+ years of experience in Regulatory Affairs or related functions
• Hands-on experience in regulatory submissions across multiple regions (U.S., EU, and/or other international markets)
• Experience supporting early-stage drug development (pre-IND through Phase 2)
• Demonstrated experience contributing to regulatory submissions and health authority interactions (e.g., pre-IND, Type B meetings)
• Strong understanding of global regulatory frameworks
• Deep understanding of the drug development process
• Ability to critically assess scientific, clinical, and CMC data in a regulatory context
• Strong communication, strategic thinking, and cross-functional collaboration skills
• Ability to manage multiple priorities in a fast-paced environment
• 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

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 a competitive company match
• Annual equity awards
• Participation in 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