Breaking News

Amgen Names Global Regulatory and Safety SVP

May 13, 2014

Galson responsible for all regulatory and patient safety functions

Steven K. Galson, M.D., M.P.H., has been appointed senior vice president, Global Regulatory Affairs and Safety at Amgen, effective May 19. Dr. Galson will be responsible for all regulatory and patient safety functions across Amgen, reporting to Sean E. Harper, M.D., executive vice president of R&D.
 
Dr. Galson joined the company in October 2010 as vice president of Global Regulatory Affairs. Prior to Amgen, he served as senior vice president for Civilian Health Operations and chief health scientist at Science Applications International Corp.
 
His 23-year career in the U.S. Public Health Service included acting U.S. Surgeon General during the Bush-Obama transition in 2009, and was the acting Assistant Secretary for Health, and deputy director and director of the FDA Center for Drug Evaluation and Research.
 
"Steven has led Amgen's regulatory team for the past three and a half years, and his success in this critical role has prepared him for these expanded responsibilities," said Dr. Harper. "Steven's deep and broad experience in both the public and private health sectors makes him an excellent choice to manage the unprecedented number of regulatory filings that Amgen has planned, and to lead our effort to continually evaluate and communicate the safety profile of our medicines."

Related Compliance:

blog comments powered by Disqus
  • Quality Risk Management

    Quality Risk Management

    Cheryl Abernathy and Bryan Sasbon, Quality Assurance Operations Manager, Ropack Pharma Solutions; QA Director & Regulatory Affairs, Ropack Pharma Solutions||September 8, 2016
    Embracing the process as a means to a strong quality culture

  • Staying Ahead in the Small Molecule Space

    Staying Ahead in the Small Molecule Space

    Dr. Matthew Moorcroft, VP Global Marketing, Cambrex||September 8, 2016
    Understand what is happening in the market and react accordingly

  • FDA & Drug Development

    FDA & Drug Development

    Rachelle Du2019Souza, Regulatory Heights Inc.||September 8, 2016
    You must perform the necessary due diligence to stay on top of regulatory developments