Tom Huijbers, MS

Advisor, Regulatory Affairs

Developing state of the art global regulatory strategies

Expertise

Tom supports clients with:

  • U.S. and EU regulatory support, including development of global regulatory strategies for products in development
  • Agency interactions with FDA and European health authorities
  • Preparation of regulatory submissions

Experience

With over 20 years of regulatory experience in the pharmaceutical industry, Tom provides expert guidance on regulatory strategy and agency submissions. His experience spans the globe; he has been actively involved in submissions and interactions with health authorities in the U.S., Europe, Japan, and Australia.

Tom began his career in regulatory affairs at Janssen Research Foundation in Belgium, and then spent several years at Johnson & Johnson Pharmaceutical Research and development in the UK. Over 16 years at Gr√ľnenthal GmbH in Germany, he developed regulatory strategies and supervised staff responsible for regulatory management of new development projects and the coordination of clinical trials. Tom also served as the U.S. and EU responsible regulatory lead during marketing registration for the analgesic tapentadol.

In addition to his work with Pinney Associates, Tom is the Head of Regulatory Affairs for Harm Reduction Therapeutics, a nonprofit devoted to saving lives from opioid overdose by making low-cost naloxone available as an OTC product.

Education

Post-graduate, Business Management, Leuven University, Belgium

  • Visiting student, Medical Chemistry and Molecular Pharmacology, Purdue University
  • MS, Medicinal Chemistry and Molecular Pharmacology, Groningen University, the Netherlands
  • MTS, Process Engineering, MBO College Arnhem, the Netherlands

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