Satyam Upadrashta, PhD, RAC, FAAPS, FRAPS

Assistant Professor, Pharmaceutics (Industrial Pharmacy)

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United States

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Timeline
About me
Senior Technical Regulatory Advisor at Merck
Education
- Osmania University
  -
  MSc, Chemistry
- Osmania University
  -
  BSc, Chemistry
- University of Iowa
  1984 - 1988
  Doctor of Philosophy (PhD) Pharmaceutics
Experience
- University of Missouri
  Jan 1988 - Jan 1992
  Assistant Professor, Pharmaceutics (Industrial Pharmacy)
  Taught undergraduate and graduate courses in Pharmaceutics. Served as major professor and graduated five PhD students. Mentored one post doctoral fellow.
- Bristol-Myers Squibb Company
  Jan 1992 - Jan 1996
  - Manager, International Formulation and Process Technology (Intercontiental)
    Jan 1995 - Jan 1996
  - Principal Process Engineer; Senior Process Engineer - Worldwide Pharmaceutical Technology
    Jan 1992 - Jan 1996
- Bristol-Myers Squibb
  Aug 1996 - Feb 2003
  Director; Associate Director; Manager - Global Regulatory Sciences CMC
- Chiron Corporation (now Novartis)
  Feb 2003 - Jan 2005
  Director, Global Regulatory Affairs CMC & International Regulatory Affairs
- Aradigm Corporation
  Mar 2005 - Mar 2009
  Vice President, Regulatory Affairs and Quality
- University of the Pacific
  Jan 2006 - now
  Professor of Pharmaceutics (Adjunct)
- Forest Laboratories
  Mar 2009 - May 2011
  Executive Director, Regulatory Affairs CMC
- Takeda Pharmaceuticals International Co.
  May 2011 - Sept 2017
  - Senior Director and Head, Global Regulatory Affairs CMC - Small Molecules
    Oct 2013 - Sept 2017
  - Senior Director and Head, Global Regulatory Affairs CMC - Small Molecules & Biologics
    May 2011 - Sept 2013
- STS Pharma Reg Solutions LLC
  May 2018 - May 2020
  Managing Member
  To assist pharmaceutical companies with the Chemistry, Manufacturing, and Controls (CMC) challenges and in enhancing probability of success in expedient product approvals.
- Merck
  Jun 2020 - now
  - Senior Technical Regulatory Advisor, Regulatory CMC
    Feb 2021 - now
  - Distinguished Scientist (Executive Director), Program Management Office, Regulatory CMC
    Jun 2020 - Jan 2021
Licenses & Certifications
- Regulatory Affairs Certifications - RAC (US); RAC (EU)
  Regulatory Affairs Professionals Society (RAPS)
Honors & Awards
- Awarded to Satyam Upadrashta, PhD, RAC, FAAPS, FRAPS
  Expert Board DFE Pharma Mar 2013 DFE Pharma Expert Advisory Board. DFE Pharma is a major manufacturer of pharmaceutical excipients based in Germany (served 2013 - 2015).
- Awarded to Satyam Upadrashta, PhD, RAC, FAAPS, FRAPS
  RAPS Fellow Regulatory Affairs Professional Society (RAPS) Oct 2012 This award recognizes senior regulatory professionals for their continued significant contributions and leadership in advancing the regulatory profession.
- Awarded to Satyam Upadrashta, PhD, RAC, FAAPS, FRAPS
  IPA President's Award Indian Pharmaceutical Association (IPA), India Mar 2012 This award recognizes those who had made significant contributions in advancing pharmaceutical sciences and the profession of pharmacy.
- Awarded to Satyam Upadrashta, PhD, RAC, FAAPS, FRAPS
  AAPS Scientific Achievement Award: Regulatory Sciences American Association of Pharmaceutical Scientists (AAPS) Nov 2010 This award recognizes outstanding regulatory scientists/professionals who have contributed significantly to the field of regulatory sciences.
- Awarded to Satyam Upadrashta, PhD, RAC, FAAPS, FRAPS
  AAPS Distinguished Service Award AAPS Nov 2008 Given by AAPS every two years, this award recognizes distinguished service in advancing the pharmaceutical sciences and the American Association of Pharmaceutical Scientists.
- Awarded to Satyam Upadrashta, PhD, RAC, FAAPS, FRAPS
  NIDA Drug Distribution Advisory Board National Institute on Drug Abuse (NIDA) Aug 2004 Invited appointment by NIDA (NIH) to serve on the Drug Distribution Advisory Board as one of four members.
- Awarded to Satyam Upadrashta, PhD, RAC, FAAPS, FRAPS
  AAPS Fellow AAPS Oct 2003 This award recognizes outstanding contributions which elevate the stature of the pharmaceutical sciences, and for professional excellence in the field relevant to the mission of AAPS.