Looking for a job

Prasad Shewale

@prasadshewale

Message

I support international pharmaceutical regulatory documentation, dossier compilation, and artwork compliance.

India

Message

What I'm looking for

I'm looking for a pharmaceutical regulatory role where I can support international documentation, dossier compilation, artwork compliance, and cross-functional coordination while building deeper regulatory affairs experience.

At Kilitch Healthcare India Limited, I supported international regulatory documentation and dossier compilation for EU, Sri Lanka, and Cambodia markets.

I coordinated with QA, QC, Production, R&D, and Microbiology teams to collect, review, track, and follow up on technical documents. I maintained batch-wise EU document trackers and monitored pending requirements.

I reviewed EU and third-party product artworks, print proofs, and regulatory queries, identifying discrepancies and coordinating corrections for EU and Dominican Republic products. I also supported Change Control, CAPA, Internal Audit, and GMP compliance activities.

My pharmacy education, clinical research and pharmacovigilance training, and academic documentation experience support my work across regulatory documentation, CTD/ACTD/eCTD awareness, and pharmaceutical compliance.

Experience

Work history, roles, and key accomplishments

Regulatory Affairs Officer

Kilitch Healthcare India Limited

Sep 2025 - May 2026 (8 months)

Coordinated with cross-functional departments for technical document collection and dossier compilation. Reviewed EU and third-party artworks, print proofs, and supported regulatory compliance activities.