Priyanka Pandit
EU Regulatory Affairs Associate at Teva Pharmaceuticals | Helping Pharma Companies to Enhance Quality of Life for Patients by Improving Global Access to Medicines
- Role
- Regulatory Affairs Associate i - Operations at Teva Pharmaceuticals
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Priyanka Pandit
A versatile and pragmatic individual with 4+ years of experience in Regulatory Affairs…
Experience
Regulatory Affairs Associate i - Operations
Jan 2023 — Present · IN
Teva Pharmaceuticals is a true generic giant serving about 200 million patients a day, offers a full spectrum of generics, API and OTC products to speciality and biological treatmentsRoles and Responsibilities: Managed regulatory publishing for EU & UK markets, delivering 50-80+ monthly eCTD post-approval submissions [ including Variation, Response, Renewal, Baseline, Withdrawal, etc ] and multiple Initial MAAs across National, MRP, and DCP procedures for generic, innovative and third-party products. Built a global Veeva Vault issue tracker, authored 2 work instructions for EU publishing process & consolidation, and also led the dossier consolidation project. Mentored new joiners and collaborated cross-functionally to ensure timely, compliant submissions.Key Accomplishments: Bagged 5 awards in the first year for quality, collaboration & delivery excellence Selected as 1 of 3 from a pool of 30 for RIM Project – Product Data Remediation. Performer of the Month (Aug 2023). Presented on \"The Boom of Biosimilars and its Regulatory Aspects\"(2024) and Post Authorisation Measures (PAMs)(2025) in knowledge-sharing session. Technologies Used: Veeva Vault RIM, Liquent InSight Publisher, Lorenz eValidator, Extedo EURS Validator and ADAM software
Education
University of Mumbai
Bachelor of Science - BS
2017 — 2020
University of Mumbai
Master of Science - MS
2020 — 2022
Guru Nanak Khalsa College of Arts Science & Commerce
Junior College
2015 — 2017
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