Varsha Mhaske
Inspired | Curious | Unbossed |Building high performing teams | Iron Lady | Passionate publisher | Global Publishing | Regulatory Operations | Project Management | Regulatory Strategy | Submission Management.
- Role
- Manager Regulatory Operations at Sandoz
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Varsha Mhaske
Performance-driven pharma professional able to deliver superior results across R&D…
Experience
Manager Regulatory Operations
Sep 2023 — Present · Hyderabad, IN
Subject Matter expert for Post approval maintenance process in Development of Veeva RIM (GLORIA). Supporting internal co-ordination with Regulatory Affairs functions and groups.• Lead and present the current process and proposed process to Veeva partners to ensure the product is developed according to company/business requirement. • Utilizing an Adonis and Jira platforms for tracking the system development through sprints.• Ensure and provide required information for integration of Publishing system, track wise and archiving in Veeva in turn testing of the same.• Point of Contact for service providing Vendors and SME for Sandoz processes. Collaboration and co-ordination to ensure the renewals, baselines are compiled and submitted in time ensuring quality. • Closely working with Operational excellence teams as a leadership team member for continuously improving the quality and lean process to meet the business objectives.• Independently Managed Short-Term projects with active collaboration with global stakeholders which involved gathering project information, laying down the process, Team onboarding and training, and actively monitoring of quality deliverables.• SME for development and testing of Resource planning Tool; to monitor and track publishing Tasks.(Sandoz Connect).• Collaboration with global stakeholders (country officers, strategists, content authors, and BPEs to arrange COPP, GMP, and M1 docs and ensure timely delivery of NS/REN/Var.• Submission Management of Renewals/New Registrations/Variations/HAQs/LCM for Latam, APAC and EMEA regions.(Submission planning, publishing, dispatch, archiving, and database maintenance).
Education
Institute of Project Management
Certification
2018 — 2018
ISBM, Pune
MBA
2008 — 2010
Padmashree Dr D. Y. Patil Vidyapeeth
Bachelor of Pharmacy (B.Pharm.)
2001 — 2005
IcBio Regulatory and Clinical Research Institute
Advanced Diploma In Clinical Research and Drug Regulatory Affairs
2009 — 2010
Iron Lady
Iron Lady Leadership Masterclass
2023
Skills
- Pharmaceutics
- Ectd
- 21 Cfr Part 11
- Validation
- Regulatory Affairs
- Lifesciences
- Regulatory Submissions
- Gcp
- Clinical Trials
- Pharmaceutical Industry
- Fda
- Ich-Gcp
- Document Management
- Regulatory Requirements
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.