Director of Regulatory Affairs

Job Summary

Leading regulatory strategy for innovative therapies, the fully remote Director of Regulatory Affairs will manage global regulatory processes for development programs, ensuring alignment with clinical objectives and regulatory requirements.

Key Responsibilities

• Serve as the global regulatory lead for assigned development programs, defining regulatory strategies and development pathways
• Develop regulatory strategies for rare disease and accelerated development programs, including orphan designation applications
• Collaborate with cross-functional teams to integrate regulatory considerations into development planning and key program decisions

Required Qualifications

• Advanced degree in a scientific discipline (Ph.D., Pharm.D., M.D., or equivalent) preferred
• For Associate Director, 7+ years of industry experience with at least 6 years in regulatory; for Director, 10+ years with at least 8 years in regulatory
• Demonstrated success in leading IND-stage programs through key regulatory milestones
• Experience with rare diseases and familiarity with expedited regulatory pathways
• Strong understanding of early clinical development and first-in-human safety considerations