ANKIT SAHA

Experience

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  Labcorp

  Sept 2020 - now

  Junior Regulatory Affairs Specialist

  1. Prepare, compile and review Regulatory/Quality documents to support submissions to various markets.2. Coordinate and interact with other applicable client departments to discuss and provide solutions to regulatory issues.3. Communicate with external sources such as agents and suppliers to request and provide documentations and data relevant to submissions.4. Address the complex regulatory activities in support of submissions.5. To assist in training and mentoring the new joiners and junior staffs.6. Working with different region like NA, EMEA, LATAM, APAC and Global with their different regulations and specifications.7. Always willing to work with a Lean Team and wear multiple hats to create smart strategies for regulatory submissions and an expanding Quality Management System8. Working in collaboration with Johnson & Johnson and their essential products like Self Care and Coametics.9. Working in GAP Evaluation of RMQ (RAW Material Questionnaire) Portal by finding out GAPS with thorough evaluation of documents provided by the Supplier and contacting with Supplier to provide for documents if not present. 10. Remediation of FG (Finished Good Product). 11. Performing RAW Check Activity from scratch, extracting out data and thorough analysis using TRU, Concerto and RMQ/ Specright Portal. Show less