Profile

Jessica Kokosinski

Contact Details

United States

Bio

I am passionate about Regulatory Affairs! I never knew this line of work existed in college and soon after graduating with a Biochemistry degree, found myself performing academic cancer research at Johns Hopkins University, School of Medicine. Quickly I learned that this was not a good fit and began researching what other roles were out there which fit my personality (analytical, detail oriented but appreciate the big picture) and my love of science. I stumbled upon Reg Affairs and have since gained considerable global Chemistry, Manufacturing, and Controls (CMC) RA knowledge and expertise (~20 years of industry experience), specifically focused on biological products. CMC is a great area but I also have been exposed to other RA activities such as ad/ promo review, labeling, and clinical regulatory. And I have liaised directly with the US FDA as a primary authorized official for blood derivative products (immunoglobulins). Also, I enjoy mentoring and coaching others and have led large, global teams of up to 60 CMC consultants (specifically on a long-term project with top-tier bio-pharmaceutical firm).

Year Entered Profession

  • 1995 - 1999

Current Organization Type

  • Consulting Firm

Highest Degree Earned

  • Baccalaureate

Regional Interests

  • Africa
  • Asia
  • Europe
  • Global
  • Latin America/Carribean
  • Middle East
  • North America
  • Oceana

Product Interests

  • API's
  • Biologics
  • Biomaterials
  • Biosimilars/Generic
  • Biotechnology
  • Combination Products
  • Generic Drugs
  • Innovative Pharmaceuticals
  • Orphan Products
  • OTC drugs