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Location: Schaumburg, IL, USA Manager, Regulatory Affairs Department: Regulatory Affairs Reports To: Sr Manager, Regulatory Affairs AND/OR Associate Director Regulatory Affairs Job Summary / Overview: The role is primarily responsible for the management and support of Pre8/8/2015 Schaumburg, IL Save This Job
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, a8/10/2015 Redwood City, CA Save This Job
Location:Audubon, PA Job Code:GMRAKB0415 Description The Group Manager, Regulatory, is responsible for preparing, submitting and gaining approval of 510(k), IDE, and PMA submissions to the U.S. Food and Drug Administration (FDA) for class II and class III products, and to8/16/2015 Audubon, PA 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,10/8/2015 Blue Ash, OH Save This Job
Regulatory Affairs Project Manager Location:Audubon, PA Job Code:RAPMCK0314 Description The Regulatory Affairs Project Manager assists in writing, submitting and gaining approval of 510(k) and IDE/PMA submissions to the Food and Drug administration (FDA) for class II and class8/16/2015 Audubon, PA Save This Job
Product Supply Cambridge, MA, United States Merrimack is a biopharmaceutical company discovering, developing and preparing to commercialize innovative medicines paired with companion diagnostics for the treatment of cancer. Merrimack seeks to gain a deeper understanding of8/15/2015 Cambridge, MA Save This Job
Position Summary: Establishes and monitors the global Clinical Supplies strategy for protocol development at the study level Ensure appropriate processes are established and implemented to ensure clinical supplies and key deliverables for each study within the program are9/21/2015 Ann Arbor, MI Save This Job
Job Code: 15-470 Location: Rockville, MD Applicants must meet the following requirements: Minimum of a Bachelor?s Degree in Nursing, Pharmacy, Biosciences, or other health-related field and a minimum of 2 years of clinical experience Pharmaceutical industry experience (3-58/29/2015 Rockville, MD Save This Job