Two Regulatory Affairs Contractors for an Early-Stage Vaccine Company

Client background

This small, privately-held biotechnology company is developing vaccines for a variety of infectious diseases including HIV, HCV, Ebola, and COVID-19. They are planning to file their first two INDs in the US this year along with some CTAs in Europe.

Challenge

Their Chief Medical Officer needed Regulatory assistance for both clinical regulatory strategy and also CMC regulatory writing for their upcoming INDs. They reached out to Dennis Partners for help in finding a Senior Clinical Regulatory Consultant and also a Regulatory CMC Contractor to support their upcoming IND and CTA filings.

Approach

Dennis Partners collaborated with the CMO to write job descriptions for both roles. We then conducted two separate searches, targeting Regulatory contractors and consultants who had vaccine experience.  We were able to find several available candidates who met the client’s qualifications within a few days of launching the search.  

Result

The CMO interviewed each candidate and narrowed down her top choices.  The CEO conducted the final interviews and they decided to initiate long-term contracts with their top two choices. Dennis Partners assisted with reference checks, background checks, timesheets and payroll processing. Both contractors started working for the client within weeks of starting the search and the client was elated!