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The Director of CMC Compliance will be proactive in providing strategic CMC direction in the implementation of quality strategies, policies, procedures and optimal infrastructure to ensure systems are aligned with company submissions, LFB Corporate Quality, and applicable external regulatory authorities. This person/position will work closely with a number of LFB France groups providing guidance and expertise on CMC matters and will work closely with internal LFB Regulatory groups/personnel and provide input/writing/review of CMC sections of filings. This person/position may be asked to represent or participate in LFB for Regulatory Agency interactions (correspondence, conference calls, in-person agency meetings, etc.).
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.
The primary responsibility of this position is the management and continuous improvement of the GCP Quality System, leading and management of GCP audits to assure that all aspects of clinical trials conducted have been executed in compliance with applicable FDA, ICH GCP Guidelines and other government and/or country specific regulations. Primary duties include but are not limited to liaises with colleagues at parent company in France, various internal departments and external groups including Contract Research Organizations (CROs), investigator sites ensuring a high level of quality and consistency across the programs and studies, development of the master audit plan as a means to ensure compliance with appropriate policies and procedures and contributions to due diligence activities as appropriate. This position will serve in an advisory/consultative role in compliance related manners, assist clinical program teams in implementing corrective and preventive actions and enable program teams to be inspection ready and support a culture of sustainable compliance. Under the direction of the Head of Quality Assurance, this position is responsible for providing strategic direction and compliance oversight to the clinical programs being managed by the LFB-USA Clinical Development organization.
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.