Robert Cool Email & Phone Number

• Advise project teams on the regulatory aspects of licensing new USDA regulated vaccine products.
• Review and submit reports, protocols, and studies related to license applications and post-license support.
• Create, update, and submit Outlines of Production for the control of licensed vaccine products.
• Work as subject matter expert for the approval of internal change controls related to regulatory aspects of currently license processes.
• Serve as Regulatory Affairs contact… Show more
• Serve as Regulatory Affairs contact for site process changes which impact products registered in Australia, New Zealand, and Japan.

St. Joseph, Missouri

Manage the transfer of pre-licenced veterinary vaccine products from R&D to production. These transfer projects require me to interface with nearly every department in the company to gather information, coordinate efforts and lead sub-teams. Responsible for post-research vaccine process development work in which I design, prepare, and execute experiments.