Vrushali Shinde

About Vrushali Shinde

Regulatory Affairs professional with 4+ years of experience supporting regulatory activities across the EU, US FDA, and Rest of World (ROW) markets. Experienced in working with Veeva Vault and Regulatory Information Management Systems (RIMS) to support end-to-end regulatory operations in alignment with global health authority requirements.Skilled in Veeva Vault dossier preparation, document authoring, review, and publishing, as well as supporting regulatory submissions, variations, and lifecycle management activities. Strong exposure to CMC documentation, ensuring compliance with regulatory guidelines and quality standards. Experienced in supporting PSUR and DSUR documentation, contributing to post-approval and ongoing safety and compliance requirements.Known for effective collaboration with cross-functional teams, including regulatory, CMC, quality, and pharmacovigilance stakeholders, to deliver accurate, timely, and compliant regulatory outcomes. Passionate about staying current with evolving regulatory requirements and leveraging digital regulatory platforms to improve efficiency and consistency.Actively seeking opportunities to grow in global regulatory strategy, submissions, and compliance, while adding value to organizations navigating complex regulatory landscapes.

Experience

1. Regulatory Affairs Consultant

   Tata Consultancy Services

   Jan 2025 — Present · Mumbai, IN

Education

• Savitribai Phule Pune University

  Bachelor of Pharmacy - BPharm, Pharmaceutical Sciences

  2017 — 2021