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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 class3/15/2016 Audubon, PA Save This Job
Department: Regulatory & Compliance 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 which3/5/2016 South San Francisco, CA 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 muscle4/4/2016 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
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
Job Description: The responsibilities of this newly created position will focus on being the lead individual supporting the development and implementation of CMC regulatory strategies for Alder BioPharmaceuticals development programs. This includes responsibility for direct3/19/2016 Bothell, WA Save This Job
Req Id 2841 - Posted 02/12/2016 - United States - Massachusetts - Cambridge - Regulatory Affairs ? Job Description Print Preview Apply Apply using LinkedIn? Save Job Email Job to Friend Return to List The Senior Manager, Regulatory Affairs, Global-CMC is responsible3/15/2016 Cambridge, MA Save This Job
Responsibilities: 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 submissions. Lead teams on the timely preparation,5/3/2016 San Francisco, CA Save This Job
Location:Audubon, PA Job Code:IRPMLB0216 Description The International Project Manager writes, submits and gains approval of product registrations and other submissions to international Regulatory agencies. This position entails development of submissions in conjunction with3/15/2016 Audubon, PA Save This Job
ID 2016-1020 # of Openings 1 Job Locations US-MD Posted Date 2/4/2016 Category Other More information about this job: Overview: Leads and drives Quality System function and associated activities Proactively provides guidance to the functional teams to ensure Quality System2/8/2016 Baltimore, MD Save This Job
Clinical Operations Cambridge, MA, United States Merrimack is a fully integrated biopharmaceutical company that views cancer as a complex engineering challenge. Through systems biology, which brings together the fields of biology, computing and engineering, Merrimack aims to4/13/2016 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?3/20/2016 Boston, MA 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. The3/9/2016 Redwood City, CA 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. The4/8/2016 Redwood City, 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