Santosh P.

Global Regulatory Scientist/CMC/Compliance Expert/Ex Julphar, Cipla, Sun & Glenmark

Role
Regulatory Affairs Manager at 辉瑞
Location
Visakhapatnam, AP, IN
LinkedIn followers
500 followers

About Santosh P.

Strategic Regulatory Affairs leader with deep global experience in CMC, regulatory strategy, and end‑to‑end submissions across small molecules, biosimilars, vaccines, and medical devices. I specialize in aligning regulatory direction with business objectives, accelerating development timelines, and reducing approval risk in complex, multi‑market environments.I lead cross‑functional regulatory operations with a strong focus on organizational readiness, quality, and compliance, while shaping forward‑looking strategies based on evolving expectations from US FDA, EMA, ICH, WHO, GCC, ASEAN, and key emerging markets. Known for influencing in matrix structures, anticipating regulatory challenges early, and driving clarity in high‑visibility decision forums.Passionate about building high‑performing teams and transforming regulatory functions into true strategic partners that enable portfolio growth and long‑term value.

Experience

  1. Regulatory Affairs Manager

    辉瑞

    Apr 2023 — Present · Chennai, IN

    Global Product Development (GPD)/ Global Regulatory Science (GRS)

Education

  • Savitribai Phule Pune University

    Master's Degree, Pharmaceutical Sciences

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Santosh P. — Regulatory Affairs Manager at 辉瑞 in Visakhapatnam, AP, IN | Unifers