Satish Rane
Regulatory Affairs Professional | Former Formulation Scientist (FD-NDDS Injectable Department)
- Role
- Assistant Manager Regulatory Affairs at Cipla
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
Experience
Assistant Manager Regulatory Affairs
Aug 2021 — Present · Mumbai, IN
Familiar with Guidelines - ICH (Quality - Q1, Q2, Q3, Q6), SAHPRA and EU. Experience of RA – filing strategies & requirements, eCTD new dossier submissions, query responses (major, minor – screening, inspectorate, quality, clinical), renewals, gap analysis, launch strategies and successful launches, variations (inspectorate, naming, quality, clinical – PV recommendations)[major, minor – Type IA, IAin, IB, II] Experience of Electronic Submission Gateways: Extedo, Lotenz, FTP, DCTM (Documentum), SAP, ELN (Electronic Lab Notebook) – VMware, Microsoft.
Education
University of Mumbai
Bachelor of Pharmacy
2012 — 2016
IPM - Institute of Pharmaceutical Management
Post Graduate Diploma in Regulatory Affairs
2019 — 2020
Maharashtra State Board of Secondary and Higher Secondary Education (MSBSHSE)
HSC
University of Mumbai
Master of Pharmacy, Pharmaceutics
2016 — 2018
Maharashtra State Board of Secondary and Higher Secondary Education (MSBSHSE)
SSC
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