Job Description
1. Develop and execute regulatory strategies for metabolic disease drug development, ensuring compliance with FDA, EMA, and global regulatory requirements.
2. Drive interactions with regulatory agencies, including pre-IND/IND submissions, NDA/BLA filings, advisory meetings, and approval processes.
3. Oversee clinical regulatory affairs (RA), ensuring alignment between clinical development and regulatory expectations.
4. Provide strategic guidance on regulatory pathways, risk assessment, and regulatory trends affecting metabolic disease treatments. Cross-functionally with clinical, medical, and commercial teams to optimize regulatory positioning.
5. Manage regulatory submissions, including INDs, CTAs, NDAs, and BLAs, ensuring timely approvals.