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
Associate Global Regulatory Writing
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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