Tapasya Pathak
Drug Regulatory Affairs Officer
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About
Results-driven Drug Regulatory Affairs professional with 2.5 years of hands-on experience in dossier preparation, submission, and lifecycle management across multiple regulatory markets. Proficient in CTD dossier preparation, with strong expertise in responding to health authority queries (MHRA, Health Canada, EMEA) and supporting successful product approvals. Seeking a challenging role in a dynamic organization to leverage regulatory expertise, ensure global compliance, and contribute to efficient approval processes while advancing professional growth.
Experience
Officer - Gracure Pharmaceuticals Limited
(2023-12)
- Handled regulatory submission for international market including UK, Europe, Canada, and Australia.
- Prepared CTD dossier in accordance with the regional regulatory requirements.
- Compiled and submitted the complete approval package for product registration
- Documents reviewed include packing and process PVR, packing and process validation protocols, BMR, BPR, Stability protocols, FP specification, Elemental impurity risk assessment, nitrosamine risk assessment, Residual risk assesment and stability data.
- Finalized the pre-EB documents and Exhibit Batch documents for seven projects.
- Played a key role in securing four product approvals within the team.
- Managed and resolved partner queries.
- Collaborated with different stakeholders like R&D, ADL, QC, QA etc.
- Prepared dossiers in CTD and ACTD format for Vietnam, Cambodia & Thailand.
- Drafted and submitted responses to regulatory authorities' queries, including MHRA, Health Canada.
Education
Bachelor of Pharmacy - Pharmacy - Aligarh College of Pharmacy (2016 - 2020)
M.Pharm - Pharmaceutics - Banasthali VidyapithUniversity (2021 - 2023)
