- Regulatory Strategy
- 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
Regulatory Submissions 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). Regulatory Lead in preparation of labeling and USPI Ensure all submissions meet global regulatory requirements and are in full compliance with applicable guidelines.
Regulatory Expertise Apply regulatory knowledge to provide strategic guidance and support cross-functional regulatory planning. Monitor regulatory trends, evolving requirements, and industry best practices to inform internal processes. Quality and Compliance Partner with Quality Assurance and Regulatory Affairs to ensure compliance with Good Manufacturing Practices (GMP) and regulatory standards. Support preparation for and participation in regulatory inspections and audits.
Cross-Functional Collaboration Work closely with teams across Clinical, Clinical Operations, Quality Assurance, Manufacturing, Nonclinical, Technical Development, and other functions to ensure regulatory alignment with overall development objectives. Regulatory Intelligence Maintain awareness of changes in the global regulatory landscape affecting company products. Evaluate the potential impact of new or revised regulations and communicate implications for development strategies and timelines.
