The primary function of this position is the daily care and maintenance of the LFB USA rabbit colony used to produce pharmaceutical products. Tasks must be carried out in accordance with Standard Operating Procedures (SOPs) and Work Instructions (WIs) and must be accurately documented to maintain compliance with FDA mandated Good Manufacturing Practices (GMPs) and USDA AWA regulations.
Oversee and direct all regulatory activities for LFB USA’s products, from preclinical research and development and the necessary statutory requirements pertaining to filings/registrations and ultimately approval as well as post-approval regulatory related activities. Responsible for the development of a regulatory strategy for the approval and commercialization of LFB USA’s products. Lead and manage a strong and diverse team within the regulatory department to achieve these goals. Responsible for developing and managing the US Regulatory Affairs budget.