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Company Overview Relypsa, Inc. is a late clinical-stage pharmaceutical company leading the discovery and development of novel non-absorbed polymeric drugs for important applications in cardiovascular and renal diseases. Relypsa's lead product candidate is patiromer, a4/12/2016 Redwood City, CA 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
COMPLIANCE Department: Finance Job Location: South San Francisco Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators as potential treatments for debilitating diseases in which muscle4/5/2016 South San Francisco, CA Save This Job
Description/Job Summary MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 200+ dedicated individuals is advancing a pipeline of product candidates to treat patients with3/27/2016 Rockville, MD Save This Job
Position Summary The Manager of Regulatory Affairs is accountable for the preparation and management of simple and complex regulatory submissions. They will act as liaison between Regulatory Affairs and other functional areas on various projects including external CROs, partners,5/26/2016 Cambridge, MA Save This Job
Job Description The Clinical Trial Manager in collaboration with the Clinical Project Manager, contributes to the operational execution of clinical studies to ensure delivery on time, within budget, and of high quality in compliance with ICH/GCP, Regulatory Authorities?4/23/2016 Boston, MA Save This Job
This newly created position will work closely with the VP Program & Portfolio Management (PM) to provide specialized cross-functional PM leadership for Alder?s drug development programs through expert planning, risk mitigation and execution. Collaborates with functional project5/20/2016 Bothell, WA Save This Job
REPORTS TO THE SENIOR MANAGER, REGULATORY AFFAIRS Responsibilities Create and maintain the manuals for a medical device, detailing Installation, Operation, Quality Assurance, Servicing, and other topics Understand validation and design change control; assist the Product5/5/2016 Mountain View, CA Save This Job
Director of Clinical Operations About Us Director of Clinical Operations SCOPE: Exciting opportunity for a highly motivated colleague, with the appropriate background, to join a growing entrepreneurial biotech, and take a hands-on leadership role in helping to bring a novel4/4/2016 Durham, NC Save This Job