4 Full-time fda jobs in Bombay, India.

... with PV regulations, including PSMF, SDEA, and other regional requirements. - Oversee preparation and submission of PV compliance reports to agencies (e.g., RBI, FDA, EMA). - Coordinate and act as primary auditor for internal/external regulatory inspections and audits. - Draft, review, and update legal and commercial contracts ...

... liquid manufacturing. - Coordinate with QC/QA for raw material approval in-process checks and final product release. - Ensure compliance with GMP ISO FSSAI / FDA (as applicable) standards. Manpower & Team Management - Manage production supervisors operators and contract workers. - Allocate manpower shift-wise to meet production ...

... dossiers under senior supervision Regulatory Compliance - Use the approved label (SmPC/PI) as the reference for claim boundaries - Apply working knowledge of FDA OPDP, ABPI, and EFPIA guidelines - Flag fair balance and off-label concerns MLR Process & Workflow - Understand the end-to-end MLR lifecycle and the distinct ...

... acument and knowledge of budgeting, forecasting and fiscal management • Strong attention to detail • Solid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc. • Good computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc. Working Conditions ...