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.