James Ottinger Email & Phone Number
Executive Vice President, Regulatory and Quality @ UroGen Pharma
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James Ottinger Location
- Philadelphia, PA, US
James Ottinger Work
- Executive Vice President, Regulatory and Quality @ (March 2020 - Present)
- Senior Vice President Regulatory Affairs @ (October 2017 - March 2020)
- Senior Vice President and Head of Global Regulatory Affairs @ (November 2012 - October 2017)
- Vice President, Regulatory Affairs, Global Branded Products @ (October 2011 - November 2012)
- Vice President, Worldwide Regulatory Affairs @ Cephalon (acquired by Teva) (June 2010 - October 2011)
- Vice President - Consulting and Compliance @ (May 2005 - April 2010)
- Regulatory Affairs @ (May 1981 - May 2005)
James Ottinger Education
- Temple University
BS (Pharmacy)
1976-1981
James Ottinger Skills
- 21 CFR Part 11
- AutoCAD
- Biopharmaceuticals
- Biotechnology
- CRO
- CTMS
- Change Control
- Clinical Development
- Clinical Research
- Clinical Trials
- Drug Development
- Drug Discovery
- EMA
- FDA
- Financial Analysis
- GCP
- IND
- Life Sciences
- Medical Writing
- Neurology
- Neuroscience
- Oncology
- Pharmaceutical Industry
- Pharmaceutics
- Pharmacovigilance
- Psychiatry
- REMS
- Regulations
- Regulatory Affairs
- Regulatory Requirements
- Regulatory Submissions
- Therapeutic Areas
- U.S. Food and Drug Administration (FDA)
- U.S. Title 21 CFR Part 11 Regulation
- eCTD
- Research
- Change Management
- Business Analysis
- u.s. Food and Drug Administration Fda
- Regulatory
- u.s. Food and Drug Administration
James Ottinger Summary
- James Ottinger, based in Philadelphia, PA, US, is currently a Executive Vice President, Regulatory and Quality at UroGen Pharma. James Ottinger brings experience from previous roles at UroGen Pharma, Teva Pharmaceuticals and Cephalon (acquired by Teva). James Ottinger holds a 1976 - 1981 BS in Pharmacy @ Temple University. With a robust skill set that includes 21 CFR Part 11, AutoCAD, Biopharmaceuticals, Biotechnology, CRO and more. James Ottinger has 4 emails and 4 mobile phone numbers on RocketReach.
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