Robert Michalik Biography

Robert Michalik, JD, RAC

Head of Regulatory Affairs & Compliance

Robert has 30 years of direct R&D development, regulatory affairs and quality compliance in biopharmaceutical, medical devices and cell & tissue therapy industries.  He is founder and principal consultant with RegulatoryPro Consulting, a small firm he launched in early 2002 that specializes meeting the needs of emerging biopharmaceutical and medical device client companies. Specific areas of expertise includes

  • Developing cell & gene therapy regulatory strategic and quality compliance planning and execution, and particularly in the areas of biopharmaceutical development, including cGMP-compliant Chemistry, Manufacturing & Control practices relating to biological drug substance and sterile drug product and analytical methods.
  • Guiding clients in US FDA and global regulatory compliance requirements relating to CRISPR-CAS endonuclease editing methods, current lentivirus and adenoassociated virus (AAV) gene delivery systems, and CAR T-cell therapeutic product production

His career began as a protein chemist working in basic and applied R&D positions, including Harvard Medical School/MGH & BWH, RepliGen, and EMD Serono.  Past regulatory client engagements included Diatide/Schering AG, Boston Scientific, Philips Medical, Millennium Pharma/Takeda, among others. Beginning in 2000 and for the next 10 years, Robert was adjunct faculty member in Northeastern University (Boston, MA) Graduate Program – Regulatory Affairs. Robert earned a bachelor’s degree in biochemistry and a doctorate in jurisprudence (J.D. law) and is Regulatory Affairs Certification (