Nilima Borkar

Associate Global Regulatory Writing @ Amgen | Ex-Pfizer

Role
Associate Global Regulatory Writing at Amgen
Location
Hyderabad, TG, IN
LinkedIn followers
500 followers

About Nilima Borkar

A PharmD professional with ~2 years of experience in regulatory writing, currently working in Global Regulatory Writing at Amgen.Previously, I worked as an Associate Scientist in Regulatory Writing and Submission Support at Pfizer, where I collaborated with cross-functional teams to develop, integrate, and review CTD Modules 2, 4, and 5. My role focused on ensuring scientific accuracy, regulatory compliance, and seamless integration of data across submission components, in line with FDA, EMA, and ICH guidelines.I hold a Doctor of Pharmacy (PharmD) and a Bachelor’s in Pharmacy (BPharm), along with certifications in Clinical Research and Pharmacovigilance. I’m passionate about supporting the development and approval of innovative therapies that improve patient outcomes.

Experience

  1. Associate Global Regulatory Writing

    Amgen

    Jun 2025 — Present · Hyderabad, IN

Education

  • S.M JOSHI Junior & Senior College

    HSC, Computer Science

  • Sadhana Girls Highschool

    SSC

  • Bharati Vidyapeeth

    Doctor of Pharmacy - PharmD, Clinical Research

  • Allana College of Pharmacy

    Bachelor of Pharmacy - BPharm

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Nilima Borkar — Associate Global Regulatory Writing at Amgen in Hyderabad, TG, IN | Unifers