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Description: Review, provide comments on, and prepare documents for submission to FDA and international regulatory authorities including protocols, investigator brochures, nonclinical and CMC amendments, and other regulatory documents. Lead teams on the preparation, review and5/16/2013 San Francisco, CA Save This Job
DEPARTMENT: Regulatory Affairs Relypsa will soon be located in Redwood City and we are hiring! Relypsa is seeking a reliable, self-motivated professional for the position of Associate Director/Director, Regulatory Affairs. This position will support Regulatory Affairs in the3/25/2013 Santa Clara, CA Save This Job
Department: Regulatory Affairs Classification: Exempt 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 Pre and Post approval regulatory3/19/2013 Schaumburg, IL Save This Job
Department: Regulatory Affairs Classification: Exempt Reports To: Associate Director Regulatory Affairs Job Summary / Overview: This role is primarily responsible for managing the development of labeling and managing key labeling systems and processes to support labeling3/19/2013 Schaumburg, IL Save This Job
POSTION: This position provides training towards full competency in Regulatory Affairs (RA). Candidates may enter with no prior experience in RA, or may have up to two years + prior RA experience with IDE/PMA exposure. The selected candidate will develop expertise in areas that5/15/2013 Marquette, MI Save This Job
Overview: Main responsibility involves reviewing protocols, writing Charters and Imaging Manuals, and reviewing the technical and medical components of study-related documents. Responsibilities: Author Independent Review Charters (Charters), Imaging Manuals (if applicable)2/5/2013 Princeton, NJ Save This Job