Nayan Kumar Patel

Experience

• 

  S Kant Healthcare Ltd.

  May 2019 - May 2019

  Internship Trainee

  I have learned about various functions and working of Industry.

• 

  Alkem Laboratories Ltd.

  Oct 2020 - Sept 2021

  Apprentice in Production department

  Responsible for carrying out all the processes as per standard operating procedures during manufacturing to ensure quality of the product and document handling.

• 

  Meril

  Sept 2023 - now

  Regulatory Affairs Officer

  Responsibility:Co-ordinating with Production, QA/QC department for documentation required for various applications i.e. Test License, Manufacturing License, Import license etc.Executing regulatory strategies at each phase of Product Life Cycle.Check & review labelling details of products by coordinating with QA, Production and R&D department.Dual use NOC Application to import Excipients/Raw materials.Coordinated and Supported the Tender team for submission of the applications i.e. Market Standing Certificate (MSC), Non-Conviction Certificate (NCC) and Free Sale Certificate (FSC) as per tender requirements.To ensure the appropriate licensing, marketing and legal compliance of the medical device.Provided tender support by maintaining and providing documents required for tender i.e. Market Standing Certificate, Non-Conviction Certificate. Keeping updates of all notifications related to Medical Devices, CDSCO, SUGAM Portal, NSWS Portal and Gazette of India websites.Preparing and updating Site Master File as per requirement on timely basis. Keeping track and update of Regulatory Status for applied applications at FDA office, FDCA office, CDSCO office.Maintaing and updating Original License File for applied applications at FDA/CDSCO office. And keeping track of approval letter from FDA/FDCA/CDSCO offices.Preparing application for amendments in Manufacturing License under Post Approval Change i.e. Change in Composition /Reagents, Process, Labeling, Additional Brands, Indication,Change in dimensions. Show less