Develop and implement Regulatory planning strategy for timely delivery of regulatory output across LFB USA and in conjunction with concurrent activities with the LFB SA (parent company in France). Organize the implementation of RA strategies for investigational products awaiting Regulatory Submission and/or FDA meeting actions and for post approval products and any products bought into the LFB portfolio.
This position is both a leadership and role-modeling project time-management and cross-program oversight position and will require extensive hands-on involvement, people skills and communication sensitivity, and contemporary cross-cultural global work experience. This position will interface with all disciplines within drug development that include (but are not limited to) CMC, Clinical, Med Writing, PV, Toxicology, Pharmacokinetics, and EU/French Project Management and Development and include individuals who may represent external partners, vendors, consultants, contractors, and stakeholders. This position requires the candidate to demonstrate foresight and analytic skills, be independent, be action oriented, be an excellent communicator with the ability to work well within international project teams to ensure all regulatory strategic events, interactions, and corporate submission timelines are met.
The Quality Assurance Specialist will perform a wide variety of activities to ensure compliance with applicable regulatory requirements by conducting data and document reviews and analysis. Writes and revises SOPs and related manufacturing documents. Will review investigations related to manufactured product. Works on problems of complexity and diversity in which analysis of data requires in depth evaluation of various factors.
Part-time temporary position where primary function is the daily care and maintenance of the LFB USA herd used to produce pharmaceutical products. Duties include basic animal husbandry, feeding, milking, cleaning of stalls and barns, and grounds maintenance. These tasks must be carried out in accordance with Standard Operating Procedures (SOPs), Standard Farm Practices (SFPs) and Work Instructions (WIs). Tasks must be accurately documented to maintain compliance with FDA mandated Good Manufacturing Practices (GMPs) and USDA regulations. Individual initiative is expected in the form of taking part in functional area focus groups, or accepting responsibility for accomplishing specific projects. Some administrative duties may be assigned.
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.