Ganesh Lawate
Regulatory Affairs Associate @Tata Consultancy Services
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WORK HISTORY
Regulatory Affairs Associate @Tata Consultancy Services
Regulatory Affairs professional with 3.6 years of experience in submission publishing and management across US, APAC, ROW and EU markets. Specialized in preparing and publishing eCTD, CTD, NeeS, and ACTD dossiers, ensuring regulatory compliance and timely submissions. Expertise in Dossier Publishing – Hands-on experience with IND, NDA, BLA, OPAR, and PSUR submissions using tools such as ORION, Liquent Insight Publisher, DocuBridge, Veeva Vault RIMS, and REDS. Regulatory Compliance & QC – Proficient in performing quality control checks with checklists, ensuring alignment with USFDA, EMA, and ICH guidelines. Submission Management – Skilled in Electronic Submission Gateway (ESG) dispatch, archival of completed submissions, and maintaining regulatory databases for submission traceability. Collaboration & Continuous Improvement – Strong experience in cross-functional coordination, supporting special projects, and contributing to process efficiency enhancements.Driven by quality, compliance, and efficiency, I am passionate about leveraging my regulatory expertise to ensure successful product approvals and to support pharmaceutical organizations in navigating complex global regulations.
EDUCATION
Dr. Babasaheb Ambedkar Technological University
Bachelor of Pharmacy - BPharm, Pharmacy
ABOUT GANESH LAWATE
I am a Regulatory Affairs professional with 3.9 years of experience in submission…
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