Sheetal G.

About Sheetal G.

At Genpact, leadership in regulatory affairs is not just about navigating complex pharmaceutical landscapes; it\'s about shaping them. Our team specializes in post-approval changes, managing renewal variations, and lifecycle management across diverse markets including Europe, Australia, New Zealand, and South Africa. The driving force behind our strategy is a rich blend of skills in CMC authoring, coupled with a deep understanding of regulatory agencies.With a steadfast focus on emerging markets, our work at Genpact has been pivotal in streamlining processes and ensuring compliance. The competencies honed at Naprod Life Sciences and prior roles have been instrumental in our success. We are committed to excellence in generic programming and good laboratory practice, ensuring that our pharmaceutical solutions meet global regulatory requirements.

Experience

1. Lead Consultant

   Genpact

   Dec 2022 — Present · Mumbai, IN

   Lead consultant at Genpact India looking after Post approval changes,renewal, variations and Lifecycle management,CMC authoring Europe and emerging markets, Australia Newzealand South Africa

Education

• D.G. Ruparel college of Arts commerce and Science Dadar

  D.G.Ruparel college, Chemistry

  2001 — 2006

• Saint Andrews college ,Bandra

  Diploma in Clinical Research

  2009 — 2009

• Mumbai University Mumbai

  Master’s Degree, Organic Chemistry

  2006 — 2009

• Mumabai University

  Msc Organic Chemistry ;Diploma in Clinical reserch, Organic Chemistry;Clinical research;Regulatory study

  2006 — 2009