Company Jobs

Bachelors degree in medical, Mechanical, Electric Life Science or other healthcare related majors. Set up new process for entering new data - Regulatory Information Management System.

Coordination of labeling review and approval throughout the E2E labeling process, which includes preparation of labeling components for submission to regulatory agencies, participation in labeling negotiations with agencies resulting in product approvals or labeling updates, and release of labeling for use throughout the company for marketed and LCM products

Assist Data Management Study Lead in maintenance of eCRF, Data Validation Specifications, and Study Specific Procedures. Manage clinical and third-party data reconciliation based on edit specifications and data review plans. ICON plc

Bachelors / Master s degree in life sciences, B.Pharm/M.Pharm or health-related field from a reputed college. Orion Pharma

Triage and manage Requests for Information (RFI) from regulatory authorities, coordinating responses with relevant stakeholders. Collect required documents for IVDR (In Vitro Diagnostic Regulation) ethics submissions and ensure compliance with country requirements

Support ICSR processing to ensure high-quality cases in a timely manner to meet all worldwide regulatory authority requirements

Monitor and verify the quality of raw materials, in-process materials, and finished products through regular inspections and testing. Investigate and resolve quality issues, deviations, and complaints related to manufacturing processes and products.

Oversee manufacturing and packaging operations at external manufacturing sites to ensure compliance with current Good Manufacturing Practices and applicable regulatory expectations.

This position involves active contribution to the Formulation ARD team in technical and operational activities such as hands-on support to formulation development in parenteral formulations and interpretation of analytical results. The incumbent will perform other duties as assigned.