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Director, Regulatory Operations at Orexigen Therapeutics, Inc. in United States

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Summary of Job:

 The Director, Regulatory Operations will be responsible for leading the day-to-day Regulatory Operations function and growing/overseeing the Regulatory Operations Team. The incumbent will be accountable for the overall planning and management of Regulatory Operations resources (internal and external) to effectively support timely and high-quality submissions to Global Regulatory Authorities (i.e., FDA, EMA, etc.). He/She will be responsible for creating/implementing operational processes and standards necessary to assure compliance with regulatory requirements and submission timelines.  He/she will remain current with evolving regulations, new Guidance and innovative practices related to electronic publishing and regulatory operations and will ensure implementation of new systems and procedures, as appropriate.

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