Aditi Roy
Regulatory Affairs (CMC) writer @Sanofi ||Ex-Associate Regulatory Affairs Manager @TCS|| Ex-@Viatris ||Ex-@Covance ||M.PHARM @BIT MESRA||
- Role
- Regulatory Affairs Cmc Writer at Sanofi
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Aditi Roy
Experienced regulatory affairs professional with over 6 years of experience in…
Experience
Regulatory Affairs Cmc Writer
Mar 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 non-complex changes, Renewals and CMC Document writing incl. SCP/eTOC preparation/filling for Renewals and Annual reportReport issues in implementing quality technical writing processes to ICMRegulatory ComplianceSupport sites in the regulatory compliance maintenance by sourcing and compiling the latest CMC dossiers and Post-Approval Changes from the company databasesTrack the due dates for Site registration and oversee progress by sitesCheck and approve the product designation across manufacturing and regulatoryTransversal ActivitiesPerform local training for sites to CMC regulatory requirements and IT toolsContribute to Global Quality reporting (KPIs)Focal point for 3rd party customer regulatory request
Education
Birla Institute of Technology, Mesra
Master of Pharmacy- Pharmaceutical Quality Assurance and Regulatory Affairs, Pharmaceutical Sciences
2018 — 2020
Maulana Abul Kalam Azad University of Technology, West Bengal formerly WBUT
Bachelor of Pharmacy - BPharm, Pharmacy
2014 — 2018
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