Looking for a job

vignesh M

@vigneshm3

I support global regulatory submissions, compliance documentation, and health authority readiness for pharmaceutical products.

India

Message

What I'm looking for

I'm looking to contribute to regulatory submissions, regulatory operations, compliance, and documentation roles where I can support health authority readiness, data integrity, and cross-functional delivery.

I've supported regulatory documentation, submissions, and compliance activities at the Pasteur Institute of India and Caplin Point Laboratories for biological and injectable products.

At Pasteur Institute of India, I maintained Module 3 CMC documentation, coordinated reports and health authority query responses, and tracked CAPA plans for 104 data integrity and cGMP deviations. I also conducted internal audits, reported 40+ production and QC findings, and supported corrective-action tracking, SOP maintenance, and document archival.

I now teach M.Pharm. graduates Good Regulatory Practices, clinical research regulations, eCTD submissions, and regulatory document preparation. My work is grounded in USFDA, CDSCO, EMA, WHO TRS, ICH, GxP, data integrity, and scientific writing.

Experience

Work history, roles, and key accomplishments

Regulatory Affairs Professional

Pasteur Institute of India

Feb 2021 - Apr 2022 (1 year 2 months)

Reviewed and maintained Module 3 CMC and supporting regulatory documentation for a biological product, ensuring compliance with USFDA, CDSCO, and WHO TRS requirements. Liaised cross-functionally with Quality, Production, and QC teams to generate periodic reports, coordinate safety reports, regulatory submissions, annual reports, and Health Authority query responses.

Regulatory Submissions WHO TRS Version Control CAPA Root Cause Analysis Data Integrity CMC Documentation Cross functional Coordination

Education

Degrees, certifications, and relevant coursework

JSS College of Pharmacy, Ooty

Master of Pharmacy, Pharmaceutical Regulatory Affairs

2017 - 2019

Grade: 8.5 CGPA

Pursued a Master of Pharmacy in Pharmaceutical Regulatory Affairs, focusing on regulatory compliance and data integrity in the pharmaceutical industry.