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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 and
5/16/2013 San Francisco, CA Save This JobDepartment: 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 regulatory
3/19/2013 Schaumburg, IL Save This JobDepartment: 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 labeling
3/19/2013 Schaumburg, IL Save This JobPOSTION: 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 that
5/15/2013 Marquette, MI Save This JobOverview: 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