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Vaishali Tiwari

@vaishalitiwari

Regulatory Affairs Executive at Sun Pharma preparing EU and other regional submissions, variations, and health authority responses.

India

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What I'm looking for

I’m looking to continue working in Regulatory Affairs, applying my experience with regional submissions, variations, labeling, and health authority responses.

At Sun Pharmaceuticals Industries, I prepare, compile, and review Module 1 and Module 3 submissions for pre- and post-approval variations across EU, Australia, New Zealand, and UK markets. My work also includes national phase submissions, labeling activity, and responses to health authority queries.

I coordinate technical data with relevant teams and communicate with regulatory agencies to clarify variation requirements. For labeling updates, I coordinate requests for new mock-ups and artwork through the AAM system and provide release confirmation to the plant.

Previously, at Mylan Laboratories Ltd. Pvt. (A Viatris Company), I coordinated Module 3 CMC documentation for new submissions and site transfers across multiple regions. I also prepared departmental SOPs in D2 Documentum and worked with SAP and Trackwise on project-related activities; at Sun Pharma, I received the Star Performer Award in 2025 and 2026.

Experience

Work history, roles, and key accomplishments

Current

Executive, Regional Regulatory Affairs

Current

Sun Pharmaceuticals Industries

Apr 2024 - Present (2 years 5 months)

Currently working on Module 1 & 3 activities for Europe, AUS, NZ & UK markets, handling pre- and post-approval variation submissions, query responses, and national phase entries. Coordinated technical data and communicated with regulatory agencies to facilitate discussions on variations.

Module 1 Module 3 Pre Approval Variations Postapproval Variations Query Management Labeling Artwork Review Regulatory Compliance eCTD Adobe Acrobat Professional Microsoft Office AAM Agile

Executive, Regulatory Affairs

Mylan Laboratories Ltd.

Dec 2018 - Apr 2024 (5 years 4 months)

Coordinated Module 3 CMC activities for new projects and site transfers across multiple regions, ensuring timely submission of responses to queries and post-approval variations for EU and US. Managed regulatory filing documents and coordinated with quality and cross-functional teams.