Director of Regulatory Affairs

Job Summary

Leading regulatory strategy for innovative therapies, the full-time Director of Regulatory Affairs will manage global regulatory pathways for development programs, ensuring alignment with business priorities while working remotely.

Key Responsibilities

• Serve as the global regulatory lead for assigned development programs, defining stage-appropriate regulatory strategies
• Develop regulatory strategies for rare diseases 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 record of regulatory success with IND-stage programs
• Experience with rare diseases and familiarity with expedited regulatory pathways
• Proven track record leading interactions with regulatory authorities