Associate Director, Regulatory Affairs

Contribute to the development and implementation of regulatory strategies aligned with corporate goals and timelines. Assist in planning and coordinating regulatory submissions and interactions with health authorities. Assist in preparation for FDA Advisory Committee meeting. Prepare, review, compile, and archive regulatory documents, including but not limited to Investigational New Drug (IND) applications, Biologics License Applications (BLA), Regenerative Medicine Advanced Therapy (RMAT) designations, Marketing Authorization Applications (MAAs), Clinical Trial Applications (CTAs), Orphan Drug Designations (ODDs), Pediatric Investigational Plans (PIPs), SUSAR reports, and Development Safety Update Reports (DSURs). Ensure all submissions meet global regulatory requirements and are in full compliance with applicable guidelines. Partner with Quality Assurance and Regulatory Affairs to ensure compliance with Good Manufacturing Practices (GMP) and regulatory standards.