Vinaykumar KM

Experience

• 

  Aurobindo Pharma USA, Inc.

  Jul 2018 - Jan 2019

  Project intern
• 

  Strides

  Mar 2019 - Mar 2021

  Regulatory Affairs Executive

  Supporting the team in review, compilation and publishing of dossiers and post approval supplements for US market.Query management and Lifecycle management of products primarily Prior Approval Supplements, CBE-30, CBE 0, Annual reports, PADER submissions, compilation of Structured Product Labeling (SPL), review of labelling and Publishing eCTD activity (Educe software)

• 

  PAREXEL International (India) Private Ltd

  Apr 2021 - now

  An adaptable professional from Pharmaceuticals/Healthcare domain of Regulatory experience. Quick learner, Proactive, Positive thinker, Initiator, Hardworking and a Team player.Holds a Master's degree in Regulatory Affairs from JSS Academy of Higher Education and Research, Karnataka.Experienced in CMC, Post approval Regulatory activities with hands on eCTD and Structured Product Labeling (SPL) tool.

  • Senior Regulatory Affairs Associate

    Apr 2024 - now

  • Regulatory Affairs Associate

    Apr 2021 - Apr 2024