Michael Kopcha's Location
Silver Spring, MD, US
Michael Kopcha's Work
- Director, (Super) Office of Pharmaceutical Quality @ FDA
- Vice President, Global R and D Franchise Head, Cough and Cold and Respiratory @ Novartis
- Vice President and Global Head, Global Product Development @ Novartis
- Global Head, New Technology and Product Innovation and acting VP and Head, Global Product Development @ Novartis
- Global Head, Pharmaceutical and Analytical Development @ Novartis
- Vice President, Pharmaceutical Development @ KV Pharmaceutical
- Vice President, Product Development @ IVAX
- Director, Therapeutic Device R and D @ Ethicon, Inc.
- Director, Strategic Life Cycle Management @ Johnson & Johnson
Michael Kopcha's Education
- Rutgers University
Ph.D. (Pharmaceutical Science)
- Rutgers University
M.S. (Pharmaceutical Science)
- Rutgers University
B.S. (Pharmacy)
Michael Kopcha's Skills
- Pharmacovigilance
- V&V
- Sales
- Regulatory Submissions
- 21 CFR Part 11
- Biopharmaceuticals
- CRO
- Cross Functional Team Leadership
- u.s. Food and Drug Administration Fda
- Product Development
Michael Kopcha's Summary
Michael Kopcha, based in Silver Spring, MD, US, is currently a Director, (Super) Office of Pharmaceutical Quality at U.S. Food and Drug Administration (Center for Drug Evaluation and Research), bringing experience from previous roles at Novartis Consumer Health/GlaxoSmithKline Consumer Health and Novartis Consumer Health. Michael Kopcha holds a Ph.D. in Pharmaceutical Science @ Rutgers University. With a robust skill set that includes Pharmacovigilance, V&V, Sales, Regulatory Submissions, 21 CFR Part 11 and more, Michael Kopcha contributes valuable insights to the industry. Michael Kopcha has 3 emails on RocketReach.
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