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 • 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 providing detailed responses to support submission processes.• Support the planning and conduct of regulatory authority interactions. Show less