Anuradha Shahane
Regulatory Affairs Specialist
- Role
- Regulatory Affairs Specialist at Paradata Software Systems Inc
- Location
- Navi Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Anuradha Shahane
In my current role as a Regulatory Affairs Specialist, I have gained extensive experience in managing regulatory submissions, including investigational new drug applications (INDAs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and post-approval submissions. I have a deep understanding of FDA and EU and regulations and guidelines, and I am well-versed in interpreting and applying them to ensure successful product approvals. Markets: US & Europe primarily.
Experience
Regulatory Affairs Specialist
Feb 2022 — Present · Navi Mumbai, IN
Education
Padmashri Dr. D.Y.Patil Institute of Pharmaceutical Science and Research, Pimpri, Pune 411018
Bachelor of Pharmacy - BPharm
2012 — 2015
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