Vineet Raikar
Motivated pharmaceutical professional seeking a role in Regulatory Affairs to apply academic knowledge and gain practical exposure in dossier preparation, CTD/eCTD submissions, CMC documentation, and regulatory data management. Eager to contribute to clinical and non-clinical data surfacing, quality assurance, and compliance with CDSCO, USFDA, and international regulatory guidelines.
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About
Motivated pharmaceutical professional seeking a role in Regulatory Affairs to apply academic knowledge and gain practical exposure in dossier preparation, CTD/eCTD submissions, CMC documentation, and regulatory data management. Eager to contribute to clinical and non-clinical data surfacing, quality assurance, and compliance with CDSCO, USFDA, and international regulatory guidelines. Skilled in research and development support, documentation practices, planning, and collaborative teamwork with cross-functional Regulatory Affairs teams.
Committed to ensuring accurate documentation, timely submissions, adherence to regulatory standards, and effective lifecycle management to support successful product approvals and organizational growth.
Experience
Internship Training at Researium Labs (2025-08-28 – 2025-09-26)
Quality Assurance (QA), Quality Control (QC), & Production for Pharmaceutical Industry
- Quality Assurance (QA): SOPs, Master Formula Records, Batch Manufacturing Records, CAPA reports, audits, and documentation control.
- Quality Control (QC): Analytical method validation, specifications, COAs, instrument calibration, OOS handling, stability studies.
- Production & Warehouse Operations: Equipment cleaning, yield reconciliation, packaging records, inventory management, temperature monitoring, and GMP compliance.
Hospital Pharmacy Training at KLE Dr. Prabhakar Kore Hospital & MRC (2023-07-01 – 2023-07-31)
150 hours of hands-on exposure to hospital pharmacy operations
- Prescription Analysis, Medication use, ADR and Side-effect assessment
- Cytotoxic drug handling, Hospital formulary, Bulk drug storage
- Nurse station workflow, Essential medicines management, and Ward rounds
- ADR reporting in VigiFlow, Patient counselling, and Hospital waste management
Education
Master in Pharmacy in Pharmaceutical Quality Assurance – KLE College of Pharmacy, KLE Academy of Higher Education and Research (2024-01-01 – 2026-12-31)
Bachelor in Pharmacy in Pharmacy – KLE College of Pharmacy, KLE Academy of Higher Education and Research (2020-01-01 – 2024-12-31)
Class XII (PUC) in Science – Govindram Seksaria Science College (2019-01-01 – 2020-12-31)
Class X (SSLC) – Karnataka Law Society (KLS) English Medium High School (2017-01-01 – 2018-12-31)
