Associate Director, Regulatory Affairs

Role: Associate Director, Regulatory Affairs, supporting clinical regulatory strategies across regions for biopharmaceutical programs. Responsibilities: develop and execute regulatory plans, prepare INDs and submissions, manage health authority interactions, provide guidance to cross-functional teams, ensure compliance with global regulations, monitor regulatory developments, and contribute to process improvements. Requirements: Bachelor's in life sciences with 10+ years in biopharma, including 8+ years in regulatory affairs; experience managing INDs and regulatory submissions; strong communication skills; ability to work in fast-paced, global environments. Preferred: advanced degree (MS, PhD, PharmD), knowledge of US/EU regulatory processes, and experience supporting health authority engagements. High-Value: focuses on clinical stage (IND supporting), with cross-regional responsibilities, and interaction with regulatory authorities; based remotely with no travel specified.