Terri Genthe Email & Phone Number
Chief Quality and Regulatory Officer - Regulatory and Quality @ Minervax ApS
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Terri Genthe Location
- Pottstown, PA, US
Terri Genthe Work
- 2024 -now Chief Quality and Regulatory Officer - Regulatory and Quality @
- 2023 -2024 Vice President Regulatory Affairs @
- 2018 -2023 Vice President - Regulatory Consulting and Solution Architecture @ Genpact Pharmalink
- 2013 -2017 Vice President, Global Regulatory Operations @ Teva Pharmaceutical Industries Ltd.
- 2008 -2012 Senior Director - Worldwide Regulatory Strategy @
- 2006 -2008 Member ERS @
- 2002 -2008 Senior Director - Head of Global Regulatory Submissions Management @
- 2001 -2002 Senior Manager - Regulatory Strategy @ Centocor
- 1997 -2001 Senior Manager - Regulatory Strategy @
- 1994 -1997 Sr. Scientist - Analytical Sciences and Quality Control @
- 1984 -1994 Scientist II Toxicology and Drug Metabolism @ Ciba-Geigy
Terri Genthe Education
- The Johns Hopkins University
MS (Biotechnology)
1995-1998 - William Paterson University of New Jersey
Bachelor of Science - BS (Biology, cum laude)
1985-1989 - County College of Morris
AAS (Medical Technology)
1981-1983
Terri Genthe Skills
- Leadership
- EMA
- Key Performance Indicators
- Digital Innovation
- Budgeting
- ICH
- Drug Discovery
- Medical Research
- Corrective and Preventive Action (CAPA)
- Regulatory Requirements
- Good Laboratory Practice (GLP)
- Presentation Skills
- Agency Relations
- Assay Development
- Marketing Authorisation Application (MAA)
- International Regulations
- Cross-functional Coordination
- Annual Reports
- Good Manufacturing Practice (GMP)
- Quality Assurance
- Regulatory Compliance
- Biopharmaceuticals
- Pharmaceutics
- CMC Regulatory Affairs
- Regulatory Labeling
- Regulatory Strategy Development
- Executive Management
- Global Regulatory Compliance
- Drug Development
- eCTD
- Vaccines
- Toxicology
- Cross-functional Team Leadership
- Change Management
- proteins
- Biotechnology
- Electronic Common Technical Document (eCTD)
- FDA
- IND
- Pharmaceutical Industry
- Regulatory Affairs
- Regulatory Submissions
- Validation
- Clinical Development
- Clinical Trials
- Clinical Research
- GCP
- Good Clinical Practice (GCP)
- Protein Chemistry
- SOP
- Standard Operating Procedure (SOP)
- U.S. Food and Drug Administration (FDA)
Terri Genthe Summary
- Terri Genthe, based in Pottstown, PA, US, is currently a Chief Quality and Regulatory Officer - Regulatory and Quality at Minervax ApS. Terri Genthe brings experience from previous roles at GeoVax Labs, Inc., Genpact Pharmalink, Teva Pharmaceutical Industries Ltd. and Pfizer. Terri Genthe holds a 1995 - 1998 MS in Biotechnology @ The Johns Hopkins University. With a robust skill set that includes Leadership, EMA, Key Performance Indicators, Digital Innovation, Budgeting and more. Terri Genthe has 2 emails and 1 mobile phone numbers on RocketReach.
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