VIDYA T. V
Regulatory Affairs
Chennai,TN
Summary
Team Lead – Regulatory operations directing submission-ready administration for clinical, safety, and CMC filings across global markets. Leads formatting and quality checks on Word and PDF documents to keep dossiers compliant and ready for submission. Trains and mentors a 20-member team on client-specific standards and regulatory publishing requirements.
Overview
1
1
Language
17
17
years of professional experience
Work History
Team Lead – Regulatory operations
Navitas Lifesciences Private LTD.
09.2025 - Current
- Led Submission Ready Administration team, overseeing formatting and quality check of clinical, safety, and CMC documents for global regulatory filings, ensuring high standards for submission.
- Ensured proper formatting of Word and PDF documents, maintaining full compliance and optimizing for seamless dossier compilation and submission to international regulatory authorities.
- Trained and mentored 20-member team on submission-ready standards and client-specific guidelines, enhancing compliance across all deliverables.
- Key responsibilities:
Senior Associate – Regulatory Publishing
Navitas Lifesciences Private LTD.
08.2024 - 09.2025
- Oversaw daily workload distribution and optimized workflow for 20-member regulatory publishing team, enhancing operational efficiency.
- Served as Subject Matter Expert (SME), providing advanced technical support for CMC, IMPD, and major US, Canadian (CA), and European (EU) regulatory submissions, ensuring compliance and accuracy.
- Directed training and mentoring for 20-person team on core regulatory publishing standards, tools, and compliance guidelines, fostering professional development.
- Key responsibilities:
Sr.Executive – Regulatory Affairs
AGILA SPECIALITIES PVT LTD (a unit of STRIDES ARCOLAB LIMITED, Bangalore which became a part of Mylan)
04.2013 - 04.2014
- CMC Dossier compilation and review for Drug Registration and post approval changes in US, Australia and New Zealand.
- Documentation for query responses and filing variations with the respective regulatory authorities.
- Coordinating with cross-functional teams to discuss regulatory issues, present lessons learned and discuss customer comments.
- Sr.Executive – Regulatory Affairs, April 2013 – April 2014; 1 year
- Executive - Regulatory Affairs, April 2011 – March 2013; 2 years
- Key responsibilities:
Executive - Regulatory Affairs
AGILA SPECIALITIES PVT LTD (a unit of STRIDES ARCOLAB LIMITED, Bangalore which became a part of Mylan)
04.2011 - 03.2013
- CMC Dossier compilation and review for Drug Registration and post approval changes in US, Australia and New Zealand.
- Documentation for query responses and filing variations with the respective regulatory authorities.
- Coordinating with cross-functional teams to discuss regulatory issues, present lessons learned and discuss customer comments.
- Sr.Executive – Regulatory Affairs, April 2013 – April 2014; 1 year
- Executive - Regulatory Affairs, April 2011 – March 2013; 2 years
- Key responsibilities:
Executive – Regulatory Affairs
CYMBIOTICS BIOPHARMA Pvt Ltd
07.2010 - 04.2011
- Prepare and review regulatory documentation for Drug Registration in India.
- Preparation of Executive summaries for new drugs.
- Literature search for R&D on drugs which are not available in India.
- Documentation for FDA Audit.
- Documentation for pre – liaison work with Government authorities for grant of approval.
- Key responsibilities:
Trainee – Regulatory Affairs
MICROLABS LIMITED.
04.2009 - 03.2010
- Officer - Regulatory Affairs, April 2010 – May 2010; 2 months.
- Key responsibilities:
- CMC Dossier compilation and review for Drug Registration & Renewal in ROW markets.
Education
B.Pharm -
JSS College of Pharmacy
Mysore01-2008
Skills
Regulatory strategy and compliance
Submission ready administration
eCTD compilation and publishing
Regulatory publishing workflow
Submission quality review
Dossier preparation
Documentation management
CMC dossier management
Global regulatory submissions
Regulatory correspondence
Health authority publishing standards
Structured content authoring
Timeline
Team Lead – Regulatory operations
Navitas Lifesciences Private LTD.
09.2025 - Current
Senior Associate – Regulatory Publishing
Navitas Lifesciences Private LTD.
08.2024 - 09.2025
Sr.Executive – Regulatory Affairs
AGILA SPECIALITIES PVT LTD (a unit of STRIDES ARCOLAB LIMITED, Bangalore which became a part of Mylan)
04.2013 - 04.2014
Executive - Regulatory Affairs
AGILA SPECIALITIES PVT LTD (a unit of STRIDES ARCOLAB LIMITED, Bangalore which became a part of Mylan)
04.2011 - 03.2013
Executive – Regulatory Affairs
CYMBIOTICS BIOPHARMA Pvt Ltd
07.2010 - 04.2011
Trainee – Regulatory Affairs
MICROLABS LIMITED.
04.2009 - 03.2010
B.Pharm -
JSS College of Pharmacy