Senior Director, Regulatory Affairs, Global Regulatory Lead - Development Strategy

Role Overview

We're looking for a Senior Director, Regulatory Affairs, Global Regulatory Lead – 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 be responsible for formulating and implementing global regulatory strategies and plans to enable efficient, competitive product development for assigned programs.

What You Will Do

In this role, you'll have the opportunity to Lead development and execution of global regulatory strategies for clinical, pre-clinical, and lifecycle management activities for assigned programs. You'll also: 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.

Why It Might Be a Fit

You have a Bachelor’s degree in life sciences or related field along with 8+ years of experience in Regulatory Affairs, with hands-on experience in regulatory submissions across multiple regions (US, EU, and/or other international markets). You are or you also have: 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 are essential, 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.

Requirements

• Bachelor’s degree in life sciences or related field
• 8+ years of experience in Regulatory Affairs
• Hands-on experience in regulatory submissions across multiple regions (US, 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
• 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

Benefits

• Comprehensive medical, dental, and vision coverage
• Mental health support
• Annual wellbeing reimbursement
• 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
• Employee Stock Purchase Plan (ESPP)
• Company-paid life and disability insurance
• Company Learning Institute
• Employee resource groups
• Service and recognition programs
• Meaningful opportunities to connect, volunteer, and give back