Open to opportunities

Pratik User

@pratikuser4

Message

I prepare regulatory dossiers and clinical documentation for pharmaceutical product submissions.

India

Message

What I'm looking for

I'm looking to contribute to regulatory affairs or clinical research teams through dossier preparation, regulatory documentation, CTD/eCTD compilation, and cross-functional coordination while continuing to build industry experience.

At MIL Laboratories, I supported Regulatory Affairs by preparing and reviewing documents, compiling CTD/eCTD-style dossier modules, and coordinating registration records with quality and R&D teams.

I've also supported clinical research coordination at Ingenious Healthcare, managing investigator documentation, feasibility assessments, eCRF completion, subject follow-ups, and data queries to maintain regulatory readiness and dataset integrity.

My postgraduate work in Regulatory Affairs includes comparing sterile barrier system requirements across India, the United States, and Europe, as well as evaluating stability data for an antimicrobial hydrogel to support dossier inputs.

Experience

Work history, roles, and key accomplishments

Project Intern – Regulatory Affairs Department

MIL Laboratories Pvt. Ltd.

Jul 2025 - Dec 2025 (5 months)

Supported the Regulatory Affairs team by preparing and reviewing regulatory documents to align with internal standards and submission timelines. Compiled sections of product dossiers, coordinating inputs from cross-functional teams to build complete CTD/eCTD-style modules.

Regulatory Documentation Dossier GMP Compliance ICH Guidelines Cross functional Coordination SUGAM Portal Time Management Teamwork