Yogesh B. Khedekar

About Yogesh B. Khedekar

Regarded as Regulatory expert, I present myself as result oriented Regulatory Professional familiar with ICH guidelines and completed 6+ years of experience in Drug Regulatory Affairs. Responsible for implementing CMC regulatory strategies for assigned pharmaceutical products with global regulations, guidance and defined regulatory strategies. Preparation of quality dossier (eCTD, CTD, ACTD and Checklist) with regulatory compliance with respect to country requirement. CMC authoring as per dossier format and country wise requirements. Post approval change for global market. Preparation of e-CTD dossier submission by using educe, Trackwise. Review of technical documents such as BMR, Process Validation Report, Analytical Method Validation Report, Stability Study Report and all other documents pertaining to product registration Checking and developing text matter in Artworks (i.e. leaflets, carton & foil) as per requirement such as specific storage condition. Review of Dossiers, Responsibility for Compilation of Dossiers. Co-ordination in query response after regulatory submission. Synchronize with various departments (production, quality control, and quality assurance, R&D, F&D) to collect required input for timely regulatory submission of products. Responsibility for Maintenance of Records of all the above documents. US/China Annual Reports.

Experience

1. Lead Associate -global Regulatory Affairs (Cmc)

   Genpact

   Jul 2022 — Present · Mumbai, IN

Education

• Savitribai Phule Pune University

  B.pharmacy

  2012 — 2016

• S.G,vidyalaya,kopargaon.

  10th

  2012 — 2016

• Rajiv Gandhi Business school

  Master of Business Administration - MBA

  2018 — 2018

• Mumbai Educational Trust, MET League of Colleges

  Master of pharmacy

  2017 — 2018

• Mumbai Educational Trust, MET League of Colleges

  PG course