Megha CK

Experience

• 

  Vimala hospital calicut

  Jun 2019 - Jul 2019

  Pharmacist trainee
• 

  McW Healthcare

  Mar 2021 - May 2021

  Student Trainee
• 

  Micro Labs Limited

  Aug 2021 - Apr 2023

  Expertise in preparing, compilation and review of regulatory documents / dossiers Module 1,2 and 3 for Pharmaceuticals (generic products)for International Markets.Handling queries or deficiencies received from the regulatory agencies and customers.Working with health authorities / agents to support new or existing registrations.

  • Regulatory Affairs Executive

    Aug 2021 - Apr 2023

  • Regulatory Affairs Executive

    Aug 2021 - Oct 2022
• 

  Merck Healthcare

  Apr 2023 - now

  Associate Regulatory Product Coordinator

  Contributed to Global Regulatory submission and compliance activities for Initial MAAs, Renewal and Post-approval variations for the EU, US and ROW countries.Authoring, reviewing and compilation of Administrative and Regional documents as per the requirements including legal documents such as CPP, GMP etc.Additionally, I was also involved in coordination activities with different stakeholders for different products and Veeva RIM activities.