Sainath Reddy Kasha
Manager @ Genpact | Regulatory Compliance, Submission Management
- Role
- Manager at Genpact
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Sainath Reddy Kasha
Over 13+ years of experience in Pharmaceutical Industry and currently working as…
Experience
Manager
Dec 2022 — Present · Hyderabad, IN
Proficient in assembly, compilation, and dispatch of US and Canada submissions using Liquient IP and Veeva document management tool.• Skilled in resolving queries and troubleshooting technical validation issues in eCTD submissions.• Expertise in publishing various submissions, including variations, safety reports, annual reports, adpromo submissions, DSUR, and PBRER.• Oversee day-to-day submissions and conduct final peer-quality checks.• Provide regular updates to senior management on submission progress.• Mentor new resources on business and submission processes, addressing publishing-related queries.• Bridge communication between junior associates and senior management, delivering daily project updates.
Skills
- Regulatory Documentation
- Regulatory Requirements
- Ich-Gcp
- Gcp
- Regulatory Operations
- Validation
- Ectd
- Spl
- Evmpd
- Glp
- Biotechnology
- Business Analysis
- Good Laboratory Practice (Glp)
- Clinical Trials
- Pharmacology
- Regulatory Submissions
- Nees
- Pharmaceutical Industry
- Sop
- Fda
- Good Clinical Practice (Gcp)
- Electronic Common Technical Document (Ectd)
- Gmp
- Standard Operating Procedure (Sop)
- U.s. Food and Drug Administration (Fda)
- Regulatory Affairs
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