Syed Fowzan

Detail-oriented Pharm.D graduate with 1+ year of hands-on experience in regulatory documentation, drug safety operations, and clinical data compliance within a hospital-based clinical research setting. Skilled in preparing and reviewing regulatory-compliant documentation aligned with ICH-GCP, CDSCO, and GVP guidelines, with working knowledge of CTD/eCTD dossier structure, 21 CFR requirements, and NDA/ANDA submission frameworks. Demonstrated ability to maintain 100% regulatory compliance across 150+ case documentation reviews, with a consistent record of audit readiness and zero data discrepancies.

Seeking a Regulatory Affairs Associate / Executive role in Bangalore.

Pharm.D Intern — Clinical Pharmacology & Regulatory Documentation - Sree Siddaganga Medical College & Research Institute - Tumkur

(2024-11 - 2025-11)

• Prepared, validated, and quality-reviewed 150+ regulatory case documentation records in compliance with ICH-GCP, CDSCO, and GVP Module VI standards — achieving zero documentation errors across internal audits.
• Authored regulatory-compliant safety and case narratives for Adverse Events (AEs) and Serious Adverse Events (SAEs), ensuring readiness for regulatory submission across multiple therapeutic areas.
• Applied structured coding and causality assessment standards (WHO-UMC scale) while maintaining 100% data integrity in regulatory tracking systems.
• Conducted literature screening and compliance monitoring activities, improving case follow-up response rate by 30% through systematic review of published safety data.
• Coordinated with clinical and regulatory teams to ensure timely submissions and adherence to statutory reporting timelines (7-day/15-day regulatory reporting).
• Supported documentation for medication reconciliation and ADR monitoring across inpatient wards, contributing to hospital regulatory compliance programme.
• Streamlined case intake and documentation workflows, contributing to a 25% improvement in regulatory documentation efficiency.

Doctor of Pharmacy - Pharmacotherapeutics, Pharmacology - Sree Siddaganga College of Pharmacy, Tumkur (2019 - 2025)