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Job Summary: Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as4/9/2016 Lexington, MA Save This Job
Location: Schaumburg, Illinois, USA Senior Associate, Regulatory Affairs Reports To: Senior Manager, Regulatory Affairs Job Summary / Overview: Responsible for the support of Pre and Post approval regulatory affairs activities as directed by the Senior Manager which may4/10/2016 Schaumburg, IL Save This Job
Job ID87 OverviewResponsible for independently developing regulatory strategy and filings (e.g. Annual Reports, Supplements, CBEs (Changes Being Effected), Protocols, etc.), providing critical review of CMC (Chemistry, Manufacturing, and Controls) and clinical submissions,4/4/2016 Blue Ash, OH Save This Job
The Associate Director/Director, Regulatory Operations reports to the VP Regulatory Affairs. This position is responsible for the oversight and management of day-to-day Regulatory submissions to Global Health Authorities (i.e., FDA, Health Canada, EMEA, SFDA, etc.). This5/3/2016 San Francisco, CA Save This Job
Location:Audubon, PA Job Code:IRALB0516 Description The International Regulatory Associate maintains CE Technical Files and registrations for international Regulatory agencies. This position entails working knowledge of products under review and of relevant regulations and5/17/2016 Audubon, PA Save This Job
Position Overview This position reports to the Director of Clinical Operations. This position will be responsible for supporting management of clinical trials sponsored by Relypsa. Qualified candidate must have experience in managing contract service providers, including5/12/2016 Redwood City, CA Save This Job
Director of Quality AssuranceEmail inShare Location: East Windsor, NJ Aprecia is a specialty pharmaceutical company committed to transforming customers' experience with highly prescribed high-dose medications. Built upon our proprietary three-dimensional printing (3DP)5/4/2016 Blue Ash, OH Save This Job
Company Overview Relypsa, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of polymeric medicines for patients with conditions that are often overlooked and undertreated and can be addressed in the gastrointestinal tract. The4/12/2016 Redwood City, CA Save This Job