Rohith Madhavan

M.Pharm graduate specializing in Regulatory Affairs with hands-on experience in CMC documentation, post-approval variation tracking, and eCTD submission support across FDA, EMA, and ICH frameworks. Strong grounding in CMC regulatory strategy, dossier lifecycle management, and cross-functional QA/RA coordination within GMP/GDP-compliant, SOP-driven environments. Seeking to apply CMC regulatory expertise to support global submission strategy and compliance in a fast-paced pharmaceutical organization.

Regulatory Affairs Intern - Softgel Healthcare Pvt. Ltd. - Chennai

(2025-09 - 2026-02)

• Prepared and reviewed CMC documentation and regulatory dossiers aligned with FDA, EMA, and ICH guidelines, supporting US and EU submission readiness
• Tracked post-approval variation filings, registration status, and license renewal documentation across jurisdictions, ensuring timely and compliant updates
• Supported eCTD submission deliverables for product dossiers, ensuring accuracy, consistency, and compliance with health authority formatting standards
• Conducted data integrity reviews on CMC documentation, contributing to GMP/GDP-compliant quality documentation within SOP-driven workflows; collaborated with cross-functional QA/RA stakeholders to align submission timelines

Master of Pharmacy - Regulatory Affairs - SRM College of Pharmacy, Chennai (2024-08 - 2026-05)

Bachelor of Pharmacy - SRM College of Pharmacy, Chennai (2021-10 - 2024-05)