Sampada Jonjale
eCTD Publisher - Manager (Reg Ops) at Genpact India Pvt. Ltd.
- Role
- Ectd Publisher - Lead Consultant (Team Lead) at Genpact
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Sampada Jonjale
Having about 15+ years experience in International regulatory affairs & 6 years in QC.
Experience
Ectd Publisher - Lead Consultant (Team Lead)
May 2014 — Present · Mumbai, IN
Worked on eCTD/NeeS (Non e-CTD electronic submission) using (Extedo – eCTD manager Software and EURS-Validator), activities involved –1. Published Initial MA (Original submission), Lifecycle Maintenance, Renewals and Line Extensions by DCP/MRP procedure in EU countries.2. Published NDA and IND application for submission to USFDA.3. Well versed with eCTD application tool.
Education
Patkar college
Bachelor of Science (BSc), Chemistry
1997 — 1999
University of Mumbai
Hsc, science
1995 — 1996
Skills
- Pharmaceutical Industry
- Sop
- Fda
- Regulatory Submissions
- Ectd
- Electronic Common Technical Document (Ectd)
- Pharmacovigilance
- Gmp
- Pharmaceutics
- Good Laboratory Practice (Glp)
- Standard Operating Procedure (Sop)
- Regulatory Requirements
- Validation
- Glp
- Regulatory Affairs
- Clinical Trials
- U.s. Food and Drug Administration (Fda)
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.