9 fda jobs in Bombay, India.

... develop, maintain, and debug C# applications and database solutions. The role involves creating APIs, user interfaces, and data processing systems while adhering to FDA regulations in a collaborative R&D environment. Responsibilities - Develop and maintain C# applications, APIs, and database functions for data processing and ...

... 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 ...

... experience with ICF, DCGI, import/export, and EC/IRB submissions - Experience negotiating site contracts and engaging with regulatory authorities - Based in Mumbai or nearby location - Strong ICH GCP, FDA guidelines, and clinical monitoring process knowledge - Leadership, planning, interpersonal, and financial acumen skills []

... 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 ...

... SAP/ERP supply chain touchpoints (e.g., ROH, HALB, WIP, SKU) and how they integrate with PLM data. - Familiarity with regulatory compliance frameworks (e.g., FDA, GHS) and system validation principles. Soft Skills - Analytical Problem Solving: Ability to diagnose and solve complex cross-system master data alignment issues ...

... Risk & Safety Management - Ensure proper medication storage (e.g. storing vaccines at 2–8°C). - Regularly monitor room and refrigerator temperatures according to FDA guidelines. - Conduct monthly checks to identify medications nearing expiration (within 3 months). - Organize and arrange medicines in designated bins under the ...

... that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 80% of the drugs approved by the FDA in the last five years. We’re committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based ...