Smruti Salunke

B.Pharm graduate currently pursuing a Post Graduate Diploma in Regulatory Affairs, with hands-on exposure to GMP-regulated manufacturing, documentation practices, and quality systems. Seeking a Regulatory Affairs Associate / Graduate Trainee role to contribute to dossier compilation (CTD/ACTD), regulatory documentation, and drug registration support for domestic and export markets, while building expertise in ICH guidelines and eCTD submission processes.

Industrial Trainee at Pharmax India Pvt. Ltd. (2025-07 – 2025-08)

• Gained practical exposure to Good Documentation Practices (GDP), Batch Manufacturing Records (BMR), and logbook maintenance — directly relevant to regulatory dossier support and compliance documentation.
• Observed Quality Management System (QMS) operations, including process deviations, CAPA handling, and SOP compliance, supporting understanding of Quality–Regulatory coordination.
• Built practical understanding of batch processing and manufacturing workflows within a GMP-regulated environment, relevant to reviewing manufacturing data for regulatory filings.

Post Graduate Diploma in Regulatory Affairs in Regulatory Affairs – R.J. College, Ghatkopar (2026)

Bachelor of Pharmacy in Pharmacy – Yamunabai Narayan Patil College of Pharmacy, Palghar (2026)

HSC (12th) – SS & LS Patkar Varde College, Mumbai (2022)

SSC (10th) – St. Arnold's High School, Mumbai (2020)