Nagesh N

Aggregate Report_RegVault Specialist | Veeva | Regulatory Affairs | RIMS | xEVMPD | IDMP | SPOR | Pharmacovigilance

Role
Senior Process Associate at Tata Consultancy Services
Location
Thane, MH, IN
LinkedIn followers
500 followers

About Nagesh N

A Regulatory Specialist and Clinical Pharmaceutical Industry Professional with extensive experience of document publishing, submission compilation, life cycle management and dispatching global regulatory submissions compliant with Health Authority electronic requirements.

Experience

  1. Senior Process Associate

    Tata Consultancy Services

    Mar 2024 — Present · Thane, IN

    Aggregate Report RegVault Specialist with expertise in managing safety reports, regulatory submissions, and compliance monitoring. Adept at ensuring accuracy, timeliness, and adherence to international regulatory standards.2. Optimized regulatory operations, submissions managment through Veeva RIMS by developing objectives and submission contentplan, archivals and cancellations that enhanced submission efficiency.3. Coordinating with stakeholders from Regulatory,Pharmacovigilance, IT, and business units to optimize submission processes, ensuring smooth workflow and on-time deliveries.4. Conducted Quality analysis while implementing Agile SCRUM practices, facilitating daily team meetings and efficient task management.

Education

  • Dayananda Sagar Institutions

    Master of pharmacy, Pharmacology

    2019 — 2021

  • Jain (Deemed-to-be University)

    Master of Business Administration - MBA, Data Science and Data Analytics

  • Mallige College of Pharmacy

    Bachelor of Pharmacy - BPharm, Pharmacy

    2015 — 2019

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Nagesh N — Senior Process Associate at Tata Consultancy Services in Thane, MH, IN | Unifers