Saravanan R
Regulatory affairs Senior Executive at Caplin Steriles Limited
- Role
- Regulatory Affairs Senior Executive at Caplin Steriles Limited
- Location
- Chennai, IN
- LinkedIn followers
- 500 followers
About Saravanan R
Executive In Regulatory Affairs: Dossier preparation, reviewing and submission for US and Canada market submissions. Review/Gap analysis of dossier for various regulatory filings. Responsible for submission of responses to queries /deficiencies by the agency on the submitted dossiers, by coordinating with CFT. Peparing eCTD dossier and SPL using software (PharmaReady) and making submissions to FDA and other regulatory authorities. Review & authorization of all technical document (specifications, STP and COA) and also protocol and report as per Regulatory aspects (e.g. Stability, Analytical method validation, DMF’s etc.) Co-ordination with various departments like production, QA, QC, R&D for Regulatory documents. Compile and maintain regulatory documentation databases or systems.
Experience
Regulatory Affairs Senior Executive
Jul 2021 — Present · Chennai, IN
Education
C.L. Baid Metha College Of Pharmacy
M pharmacy
2018 — 2020
C.L. Baid Metha College Of Pharmacy
Bachelor of Pharmacy - BPharm
2014 — 2018
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.