Quality and Regulatory Affairs Manager, Vista, CA - KatalystHLS.com Planning of Regulatory strategies in close association with client project goals. Prepare, assemble, and publish all regulatory documents in paper and electronic format. Participate in global product team meetings to provide Regulatory support and guidance, and to manage day-to-day Regulatory activities. Provide affiliate medical personnel with Regulatory and other associated information on a regular basis and as needed on an urgent basis. Interpret information requests, assessing the needs of the requester and prepare customized reports to meet those needs. Manage documentation of the Regulatory files to maintain quality assurance consistent with FDA, Worldwide Regulatory Authorities and other appropriate regulations. Coordinate the global Regulatory program, ensuring that all records meet GCP, FDA, other Worldwide Regulatory Authorities and company policies.
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