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
Regulatory Affairs Manager
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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