Healthcare Professional | Bridging Clinical Research & Communication | GCP-Trained | Skilled in Clinical Systems | Veeva vault

Mumbai, Maharashtra, India

Mumbai, Maharashtra, India

Mumbai, Maharashtra, India

Mumbai, Maharashtra, India



Postgraduate Degree, Clinical Research Coordinator
R J DEGREE COLLEGE
Master's degree, Bioinformatics
Guru Nanak Khalsa College of Arts Science & Commerce
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Regulatory Affairs professional transitioning from Clinical Operations with hands-on experience in scientific document review, compliance checks, and preparation of documentation packages for audits and approvals. Skilled in QA documentation safety, adherence to ICH guidelines, and cross-functional coordination with R&D, vendors, and internal stakeholders. Proficient in Veeva Vault, Excel, and technical writing. Currently upskilling in CTD/eCTD structure, submission workflows, labeling amendments, and post-approval change processes to build a career in US Regulatory Affairs. Career goal: contribute to ANDA submissions, lifecycle maintenance, and high-quality dossier compilation for regulated markets. My academic background from Guru Nanak Khalsa College with a Master's in Bioinformatics and a Bachelor's in Microbiology from Sathaye College underpins our approach to clinical trials. This education, combined with my role at TCS and C.L.A.I.M.S, enables us to refine research methodologies and contribute to the evolution of clinical practices.
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Senior Process Associate at Tata Consultancy Services, Apr 2025 - Present · 1 yr 7 mos, Mumbai, Maharashtra, India
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Postgraduate Degree, Clinical Research Coordinator, R J DEGREE COLLEGE
Master's degree, Bioinformatics, Guru Nanak Khalsa College of Arts Science & Commerce