Regulatory Affairs Cmc And Clinical Trials
Current- Develop, review, and finalize Chemistry, Manufacturing, and Controls (CMC) sections of regulatory submissions.
- Ensure adherence to global regulatory standards and requirements.
- Collaborate cross-functionally with manufacturing and quality assurance teams to maintain compliance and operational efficiency.
- Assist in the preparation and submission of regulatory files and respond to questions from the regulators.
- Liaise with regulatory agencies, addressing inquiries and… Show more
- Liaise with regulatory agencies, addressing inquiries and providing detailed responses to support submission processes.