Prasad Shewale
Regulatory Affairs Officer | Regulatory Documentation | Artwork Review | Regulatory Coordination & Compliance
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About
Regulatory Affairs professional with hands-on experience in pharmaceutical regulatory documentation, international regulatory support and artwork compliance. Experienced in coordinating with cross-functional factory departments for technical document collection, review, tracking and dossier compilation across EU, Sri Lanka and Cambodia markets. Experienced in handling EU artwork-related regulatory queries, reviewing EU and third-party product artworks and print proofs, and coordinating required artwork corrections, including support for artwork review and correction coordination for the Dominican Republic market.
Experienced in Change Control, CAPA and Internal Audit Compliance, with awareness of CTD, ACTD and eCTD documentation requirements.
Experience
Regulatory Affairs Officer - Kilitch Healthcare India Limited - Mumbai
(2025-09 - 2026-05)
- Coordinated with QA, QC, Production, R&D, Microbiology and other factory departments for collection and follow-up of technical and regulatory documents required for international regulatory documentation and dossier compilation.
- Supported EU market documentation by maintaining batch-wise document trackers and monitoring document status and pending requirements.
- Worked on EU product artworks by reviewing artwork-related regulatory queries, identifying observed discrepancies and coordinating required corrections with the concerned teams.
- Supported Sri Lanka and Cambodia market requirements by collecting required technical and supporting documents from relevant factory departments.
- Reviewed third-party artwork for the Dominican Republic market, checked print proofs, identified required corrections and coordinated with the concerned team for artwork approval.
- Reviewed BMR/BPR, finished product and raw material specifications, COAs, stability data, PVP/PVR and other supporting documents; also supported Change Control, CAPA and Internal Audit Compliance activities and maintained regulatory trackers and records.
Medical Representative - Macleod Pharmaceutical Limited
(2022-05 - 2022-11)
- Communicated pharmaceutical product information to healthcare professionals and developed understanding of product information, indications, dosage and safety-related information.
- Gained exposure to pharmaceutical products, market dynamics and competitor information, supporting broader understanding of the pharmaceutical industry.
Education
Master of Pharmacy - K.B.H.S.S. Trust’s Institute of Pharmacy, Malegaon – SPPU, Pune (2023 - 2024)
Bachelor of Pharmacy (B. Pharm) - MGV’s S.P.H. College of Pharmacy, Malegaon – SPPU, Pune (2020 - 2021)
