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1. Manage regulatory compliance and liaisoning with FDCA for API Unit.
2. Coordinate with regulatory authorities for approvals, licenses, and permits.
3. Prepare and submit regulatory documents (DMF, ANDA, NDA, etc.).
4. Ensure compliance with FDCA regulations, guidelines, and standards.
5. Conduct audits and inspections to ensure regulatory readiness.
6. Collaborate with cross-functional teams (Production, QA, R&D) for regulatory compliance.
7. Provide training on regulatory requirements and procedures.
8. Maintain records and documentation of regulatory submissions and approvals.
Master of Science (MS/M.Sc), Bachelor of Science (B.Sc)
Date Posted: 09/10/2024
Job ID: 95581951
Sri Sai Overseas Recruitments is a Manpower Recruitment and Consultancy Service provider. It was established in year 2019 and managed by Professionals previously employed in Gulf Countries in Oil and Gas Sector. The Operations are managed by Professionals who are having extensive work experience in managerial positions in Kuwait, Qatar and Oman and having the exposure to working environment, rules and regulations of Middle East countries.
Sri Sai Overseas Recruitments is having complete awareness on Client’s expectations while recruiting people from India. The primary focus is on providing Manpower Recruitment & Consultancy Services in India, Middle East, European and other Countries globally.