Rajvi Bhatt
Regulatory affairs proffesional
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About
Regulatory Affairs Officer with 3 years and 4 months of experience in the API pharmaceutical sector, specialized in regulatory submissions for USFDA, EDQM, EU and ROW markets. Skilled in preparing USDMFs / Annual reports of USDMFs, CEP (New application, Renewals & revisions), customer communication, responding to regulatory authority deficiencies as well as customer queries. Strong understanding of global regulatory guidelines including ICH, EDQM, cGMP etc., and dossier life-cycle management.
Experience
Regulatory Affairs Officer - API at Dishman Carbogen Amcis Limited (2022-01 – 2025-01)
Managed regulatory submissions and compliance for API pharmaceutical products across USFDA, EDQM, EU and ROW markets. Handled USDMF filings, CEP applications, dossier compilation, and regulatory authority deficiencies.
- Prepared, updated, and maintained USDMFs, including annual reports, amendments, and life-cycle documentation
- Managed CEP revisions, renewals, and supported new CEP applications in accordance with EDQM requirements
- Responded to regulatory authority deficiencies / queries (USFDA, EDQM) by compiling technical justification and supporting documents
- Prepared and issued Regulatory LoAs, customer declarations, and compliance certificates (GMP, TSE/BSE, solvents, allergens, etc.)
- Handled customer regulatory queries for European, US, and ROW markets, ensuring timely and complete responses
- Conducted dossier content review including process flow, analytical methods, specifications, impurity profiling, stability data, and validation summaries
- Collaborated with QA, QC, production, and R&D teams for data collection and regulatory compliance alignment
- Supported regulatory gap assessments for API documentation and recommended corrective updates
Education
Bachelor of Science in B.Sc. – Gujarat University (2019-01)
Master of Science in Organic chemistry – Gujarat University (2022-01)
