Sumitra Ghate Email & Phone Number
Vice President, Regulatory Affairs and Quality @ Prolynx
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Sumitra Ghate Location
- Indianapolis, IN, US
Sumitra Ghate Work
- 2026 -now Vice President, Regulatory Affairs and Quality @
- 2019 -now President @ Artimus Regulatory Consulting, LLC
- 2024 -2026 Senior Vice President, Global Product Development and Regulatory Affairs @
- 2021 -2023 Senior Vice President, Development and Global Regulatory Affairs @
- 2019 -2021 Engagement Partner - Regulatory Strategy @
- 2017 -2019 Sr. Director, Regulatory Affairs @
- 2015 -2017 Director, Global Regulatory Affairs - Medical Devices @ Eli Lilly and Company
- 2010 -2015 Advisor, Global Regulatory Affairs - Clinical @ Eli Lilly and Company
- 2005 -2010 Manager, Global Regulatory Affairs, CMC @ Eli Lilly and Company
- 2000 -2005 Senior Pharmaceutical Scientist, Clinical Trial Manufacturing @ Eli Lilly and Company
- 1997 -1999 Manager, Regulatory and Quality @
- 1995 -1997 Analytical Chemist @ Eli Lilly and Company
Sumitra Ghate Education
- The University of Kansas
Bachelor's Degree (Human Biology)
- The University of Kansas
Bachelor's Degree (Chemistry)
Sumitra Ghate Skills
- Cardiometabolic Therapies
- Parenterals
- High-Performance Liquid Chromatography (HPLC)
- Gas Chromatography
- Quality Control
- Supervisory Skills
- Analytical Chemistry
- Drug master file
- FDA GMP
- Technical Marketing
- Coaching
- Team Leadership
- Management
- Digital Health
- People Development
- Clinical Trial Manufacturing
- Quality Agreements
- Comparability
- CMC Core Dossier
- Quality by Design
- Small Molecules
- Clinical Protocols
- ICH
- Clinical Regulatory
- Marketing Authorization Application (MAA)
- Risk Management
- Health Canada
- MHRA
- New Drug Application (NDA)
- Investigational New Drug Application (IND)
- Risk Assessment
- Negotiation
- Biologics License Application
- Regulatory Strategy
- T cells
- Autoimmune Diseases
- Stem Cell Transplant
- Product Development
- Pre-clinical Studies
- Business Alliances
- Investor Presentations
- Regulatory Interactions
- Regenerative Medicine
- Regulatory Affairs
- Medical Devices
- Drug Development
- Regulatory Strategy Development
- Clinical Development
- FDA
- Diabetes
- Regulatory Submissions
- Combination Products
- Insulin
- Insulin Pumps
- Mobile Medical Device Applications
- Pen Injectors
- Human Factors
- Clinical Trials
- Quality System
- Pharmaceutical Industry
- GMP
- CMC
- Biotechnology
- Validation
- 21 CFR Part 11
- Technology Transfer
- Change Control
- Computer System Validation
- Oncology
- GxP
- Regulatory Requirements
- Biopharmaceuticals
- GLP
- GCP
- CRO
- Sop
- Lifesciences
- CMC Regulatory Affairs
- Import Export
- Monoclonal Antibodies
- Biologics
- Clinical Research
- Cross-functional Team Leadership
- Standard Operating Procedure (SOP)
- CRO Management
- Life Sciences
- Good Laboratory Practice (GLP)
- U.S. Title 21 CFR Part 11 Regulation
- U.S. Food and Drug Administration (FDA)
- Drug Delivery
- Cell Therapy
Sumitra Ghate Summary
- Sumitra Ghate, based in Indianapolis, IN, US, is currently a Vice President, Regulatory Affairs and Quality at Prolynx. Sumitra Ghate brings experience from previous roles at Artimus Regulatory Consulting, LLC, Adipo Therapeutics, iTolerance, Inc. and Bruder Consulting & Venture Group. Sumitra Ghate holds a Bachelor's Degree in Human Biology @ The University of Kansas. With a robust skill set that includes Cardiometabolic Therapies, Parenterals, High-Performance Liquid Chromatography (HPLC), Gas Chromatography, Quality Control and more. Sumitra Ghate has 2 emails and 1 mobile phone numbers on RocketReach.
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