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