Cheenu Gupta

Deputy Manager (Drug Regulatory Affairs) @Cipla Limited

Mumbai, IN

Module 1 documents preparation for initial MA submission to agency in Europe as per MRP/DCP/National/RUPs procedures depending upon business requirements. Responsible for Life cycle management (submission of quality, administrative and safety variations) and timely submission of renewals/sunset clause of the registered products to ensure continuous market supply.3. Submission and Implementation of FMD and Serialization as per guidance in Europe.4. Handled Brexit project independently to ensure RMS transfer from UK to Non-UK country (part of DCP/MRP) for products having UK as RMS in company portfolio.5. Responsible for all Brexit related activities for delegated products once UK leaves EU including PV activities (PSMF and QPPV variations), location of Batch release, Batch testing sites, QP certifying batch release, MA holders etc. Generation of sequences through eCTD (Extedo and Educe) and submission through agency portals (MHRA/CESP).7. Working closely with Business team to understand the business requirements and plan submission strategies and also helping them to understand the regulatory requirements with respect to implementation to ensure continuous supply.8. Responsible for launch of the product in the market in co-ordination with multiple stakeholders and perform activities like GAP analysis (comparison of registered documents and proposed BMR/Specs/methods etc), consideration of EU reanalysis sites, Batch release sites, update of eMC website for UK launch, approval of printed packaging material etc and if required, submission of variations and ensure approval on time (without invalidation and clock stop) to support launch. Responsible for compliance to manufacturing unit documents, CCDS, XEVMPD, implementation of safety variations, PSUR submissions, submission of educational materials, updated RMPs etc.10. Review of the CMC sections and support to drug safety division team and manufacturing unit to classify the change and implementation.

Punjabi University, Patiala

Bachelor of Pharmacy - BPharm, Pharmacy

Punjabi University

Master in Pharmacy, Pharmaceutical Sciences