Shalu Gupta

Experience

• 

  Plethico Pharmaceutical Ltd., Mumbai

  Sept 2012 - Sept 2014

  Jr. Officer

  • Preparation of Product Dossier for Registration/ Re-Registration in Regulated as well as Semi- Regulated countries for allopathic and herbals supplements for ASEAN, EWA, FWA and CIS, countries.• Keeping track of ever changing legislation in my region and advise on the legal and scientific restraints and requirements, and collect, collate and evaluate the scientific data generated by other internal teams.• Assist seniors in making presentation of registration documents to regulatory agencies, and research to support subsequent negotiations necessary to obtain and maintain marketing authorization for the products concerned. • Prepare strategic and technical presentations in order to assist the Regulatory Head in providing advice to the management at all stages of product development. • Be a part of the New Product Development team in the preparation of product marketing concepts and give inputs on packaging and advertising regulations of the region. • Assist the senior team members in drawing up efficient harmonization of products to match the regulations laid down by different governments and their interpretation. • Update registration dossiers; evaluate the deficiencies received from respective agencies and respond timely.• Liaison with various departments like R&D, Analytical Development, QC, QA, Production, Stability and Corporate Affairs in order to Collect, Review and Compile data as per various requirements.• Prepare checklist and Review all the documents as per the guideline.• Archiving hard copies and soft copies of dossier.• Tracking of dossier submitted to country and making updates. Show less

• 

  IMEDGlobal Solutions Private Limited

  May 2015 - May 2017

  Executive-Regulatory Affairs

  JOB RESPONSIBILITIES• Understanding the Business User requirement and the Client software FRED and RegisterTM Product functionalities.• Acting as a FRED Central Team Member managing all the requests related to new product registrations or modification of existing registration information on RegisterTM.• Interact with the Business users of markets globally for clarifications, assessing the impact of requests on RegisterTM, perform activities to replicate information in RegisterTM and coordinate with the Register Global Admin team to manage any special requests.• Performing verification of new entries or modifications in RegisterTM to ensure correctness and consistency of data as per the procedure in client repository.• Support the client if any requirement/task requires clarification and escalation through Work Instructions, SOP or as per recent updates.• Discuss with the Manager if any requirement/task requires clarification and escalation.• Involved in Project Status Meeting and provide the required status updates to Manager and Customer. Show less

• 

  British American Tobacco

  Feb 2018 - now

  Product Regulatory Compliance Manager