Rakesh Wani.
Global Regulatory Affairs CMC writer
- Role
- Global Regulatory Affairs Cmc Writer at Sanofi
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Rakesh Wani.
I hold a Ph.D. in Pharmaceutical Sciences and have over 6 years of professional experience in global drug regulatory affairs and formulation analytical R&D. I am responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in alignment with global regulations, guidance, and defined regulatory strategies. My expertise includes preparing quality dossiers (eCTD, CTD, ACTD, and checklists) in compliance with country-specific regulatory requirements, as well as managing post-approval changes (life cycle management).
Experience
Global Regulatory Affairs Cmc Writer
Jan 2025 — Present · Hyderabad, IN
Regulatory Intelligence & RequirementsCommunicate to sites the information on new regulationsList the CMC changes required on the CMC documentation impacted by the new CMC regulationsOversees the implementation of new regulations with sitesCMC Document ManagementIdentify & collect the supportive data, statements from CMOWrite CMC regulatory dossiers for single-complex changes, Renewals and CMC Document writing incl. SCP/eTOC preparation/filling for Renewals and Annual report
Education
Bhagwant University, Ajmer
Doctor of Philosophy - PhD, Pharmaceutical Sciences
Sinhgad Institute of Pharmacy, Pune
Master in Pharmacy, Pharmacy
2015 — 2017
MES college of Pharmacy Sonai
Bachelor of Pharmacy - BPharm, Pharmacy
2011 — 2015
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