Rohith Madhavan

M.Pharm (Regulatory Affairs) candidate with hands-on experience in regulatory dossier preparation, eCTD submission support, and compliance documentation across FDA, EMA, CDSCO, and ICH frameworks. Specialized knowledge in medical device regulations including FDA 510(k), EU MDR 2017/745, and CE Marking pathways. Experienced in supporting GeoX regulatory submissions, coordinating with in-country regulatory authorities, and managing product lifecycle compliance for digital and combination products.

Strong understanding of risk management, post-market surveillance, technical documentation, and regulatory lifecycle management.

Regulatory Affairs Intern at Softgel Healthcare Pvt. Ltd. (2025-09 – Present)

• Prepared and reviewed regulatory dossiers aligned to FDA, EMA, and ICH guidelines to support US and EU submissions
• Supported eCTD submission deliverables ensuring accuracy, consistency, and compliance with health authority expectations
• Gained exposure to global regulatory submission processes including post-approval variations and regulatory lifecycle management
• Assisted in CMC documentation preparation, data integrity reviews, and GMP/GDP quality documentation practices
• Developed familiarity with submission planning, regulatory clearance processes, and compliance standards across multiple jurisdictions

B.Pharm Intern at Mesmer Pharmaceuticals Pvt. Ltd. (2023-05 – 2023-06)

• Observed solid dosage form manufacturing including tablet compression and packaging operations
• Built foundational knowledge of cGMP practices, production workflow compliance, and documentation standards

Master of Pharmacy in Ph. Regulatory Affairs – SRM College of Pharmacy (2024-08 – 2026-05)

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