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Kern Health Systems

Bakersfield , California

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Denver, Colorado

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Director of Regulatory Affairs
Director of Regulatory Affairs will develop regulatory strategy and serve as regulatory lead for several programs including the renal, GI and ophthalmology programs. This individual will provide oversight of planning and execution of major submissions and responses to regulatory authorities related to IDE/PMA/IND/NDA submissions, Annual Reports, Investigator Brochures, IND amendments, briefing documents for FDA meetings, as well as responses to health authority requests. Roles and Responsibilities for the Position Responsible for planning, developing and implementing the regulatory strategy for assigned projects and programs in all stages of development. Applies global regulatory knowledge governing responsible products to contribute to the overall development strategy and will be the P

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