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| Associate Director of Regulatory MD Open (J#38718) Title: Associate Director of Regulatory Company: Kforce Job Information Title: Associate Director of Regulatory Affairs Location: Gaithersburg, MD Job Type: Direct Hire Compensation: per Year Reference Code: 990922-NRC Description: At Kforce Clinical Research, we don't just offer jobs. We offer a rewarding career experience, complete with professional development opportunities and a great benefits package! We are intelligent business partners to some of the world's most valued pharmaceutical companies and have evolved to create models of operational excellence that incorporate Lean and Six Sigma philosophies. Using these tools, Kforce is able to better plan and anticipate workloads and thus minimize the peaks of work that can swamp you. This allows you to stay just as dedicated and still strike a balance between work and home. Currently, one of our top clients is in search of an exceptional Associate Director of Regulatory Affairs in Gaithersburg, MD. The Associate Director of Regulatory Affairs is responsible for preparing, implementing, communicating, and coordinating regulatory projects, plans and schedules with scientific (clinical and preclinical), manufacturing, and business development project team members for biological products proposed for oncologic indications. This role is also responsible for collecting, preparing and assembling documentation required for Investigational New Drug Applications, and Biologic License Applications. Specific Accountabilities: - Lead innovative regulatory strategy development for all phases of drug development for biological investigational products - Monitors product related corporate activities for regulatory compliance, including all manufacturing, preclinical and clinical plans and practices - Represents Regulatory Affairs and provide guidance to Research, Development, Clinical and Manufacturing at Project Team meetings - Interacts with responsible departments and manages collection, review, and assembling of the scientific (preclinical, clinical, and manufacturing) and administrative sections of submissions to regulatory agencies More... | |||
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