Associate Director, Regulatory Affairs

Role: Associate Director, Regulatory Affairs supporting clinical regulatory strategies and submissions for biopharmaceutical programs. Responsibilities include developing and executing regulatory plans, preparing IND applications, managing health authority interactions, providing regulatory guidance to cross-functional teams, and ensuring compliance with global regulations. The role involves proactive risk management, monitoring regulatory developments, and process improvement. Requirements: Bachelor's in life sciences with 10+ years of industry experience, including 8+ years in regulatory affairs; experience preparing INDs, supporting health authority interactions, and knowledge of U.S./EU regulations preferred. High-Value: focus on clinical development, IND management, cross-functional collaboration, global regulatory compliance, and supporting innovative drug programs. Work setup: Remote, with no travel specified.