My Profile

Michael Swit, JD

Senior Director, Legal, Regulatory,
Varian Medical Systems Inc

Contact Details

Senior Director, Legal, Regulatory,
Varian Medical Systems Inc
Auburn, CA
United States
Work: +1 (650) 424-6638

Bio

Michael A. Swit, Esq., has been tackling critical FDA legal and regulatory issues since 1984. In November 2017, he returned to private law practice after 3 years as Senior Director, Legal, Regulatory, at San Diego-based Illumina, Inc., the world's leading developer of gene sequencing technologies, which he joined in December 2014. His multi-faceted experience includes serving, earlier in his career, for three and a half years as corporate vice president, general counsel and secretary of Par Pharmaceutical, a publicly-traded, generic drug company and, thus, he brings an industry and commercial perspective to his work with FDA-regulated companies. He then served for over four years as CEO of FDAnews.com, a premier publisher of newsletters and other specialty information products for the FDA-regulated community. His private FDA regulatory law practice included service as Special Counsel in the FDA Law Practice Groups of several major law firms, most recently from March 2012 to December 2014, in the San Diego office of Duane Morris LLP. From 2004 to 2011, he was a Vice President at The Weinberg Group, a preeminent FDA regulatory consulting firm. Mr. Swit has lectured and written on a variety of subjects relating to FDA law, regulation and related commercial activities, and is a former member of the Food and Drug Law Journal Editorial Board. He earned his A.B., magna cum laude, with high honors in history, from Bowdoin College and his law degree at Emory University School of Law. Mr. Swit currently is a member of the California bar and inactive in D.C. and Virginia.
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Education

Emory University School of Law
Atlanta, Georgia, United States
Juris Doctor, 1982
Law
1979 To 1982

Bowdoin College
Brunswick, Maine, United States
A.B., magna cum laude, with High Honors in History, 1979
Chinese History
1974 To 1979
Dissertation: Chinese Political Vacillations and the Sino-Soviet Dispute: A Model for Conceptualizing the Dynamics of Contention
Advisor: John Langlois, Ph.D.

Job History

For a comprehensive biography, including my job experience, see my LinkedIN profile at https://www.linkedin.com/in/michaelswit/

Sectors of Interest

  • Advertising, Promotion and Labeling
  • Clinical Trials
  • Compliance
  • Ethics
  • Preclinical study
  • Product Lifecycle
  • Professional Development/Training
  • Quality Assurance and Control
  • Regulatory Intelligence/Policy
  • Research, Design and Development
  • Supply Chain Management

Education

  • Doctorate degree (PhD, ScD, MD, DVM, DMD, PharmD or other clinical doctorate, etc.)

Professional Areas of Interest

  • Advertising, Promotion and Labeling
  • Clinical Trials
  • Compliance
  • Ethics
  • Preclinical study
  • Product Lifecycle
  • Professional Development/Training
  • Quality Assurance and Control
  • Regulatory Intelligence/Policy
  • Research, Design and Development
  • Supply Chain Management

Regional Areas of interest

  • Global

Professional Interests

  • Advertising, Promotion and Labeling
  • Clinical Trials
  • Compliance
  • Ethics
  • Preclinical study
  • Product Lifecycle
  • Professional Development/Training
  • Quality Assurance and Control
  • Regulatory Intelligence/Policy
  • Research, Design and Development
  • Supply Chain Management

Year Entered Profession

  • 1980-1984

Highest Degree Earned

  • Doctorate degree (PhD, ScD, MD, DVM, DMD, PharmD or other clinical doctorate, etc.)