Director, Regulatory Affairs
Mike joined Klein Hersh in 2017 to support the rapid growth of KHI’s Regulatory Affairs practice. As a member of the Regulatory team, Mike’s focus is to help expand the practice as well as continue to strengthen the relationships with current clients within seed-stage companies, small to mid-sized biotech, and large pharmaceutical companies.
KHI’s Regulatory team actively participates in the Regulatory Affairs Professionals Society (RAPS), Drug Information Association (DIA), and other trade associations.
Prior to Klein Hersh, Mike spent 4 years in the financial services industry where he had tremendous success both regionally and nationally.
- Chief Regulatory Officer, Immuno-Oncology
- VP of Regulatory Affairs, Oncology
- VP of Regulatory CMC, Infectious Disease
- VP of Regulatory Affairs, Gene Therapy
- VP of Regulatory Affairs, CNS
- Head of Regulatory Affairs, Cell Therapy
- Head of Regulatory Affairs, Immunology
- Head of Regulatory Affairs, NASH
- Head of Regulatory CMC, Microbiome
- Head of Regulatory Affairs, Rare Diseases
- Executive Director Regulatory Affairs, Cardiovascular
- Senior Director, Regulatory Affairs, Advertising & Promotional Review
- Director, GRL, Immuno-Oncology
- Director, GRL, CNS/Immunology
- Director, Regulatory Affairs CMC, Biologics, Small Molecules & Vaccines