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Location:Pleasanton, California DESCRIPTION Summary: Provide leadership over the Regulatory Affairs function to ensure the departmental activities align with overall Company goals and strategies. Responsible for establishing and administering sound Regulatory policies,4/24/2016 Pleasanton, 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 muscle4/5/2016 South San Francisco, CA 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
Position Summary We are seeking a talented, highly motivated and experienced regulatory affairs professional to join our fast-growing company. The Vice President of Regulatory Affairs will be responsible for developing the global regulatory strategy for development-stage3/23/2016 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
Morrisville, NCFull-time Company Description Liquidia Technologies, founded in 2004, is a privately held biotechnology company located in Research Triangle Park, North Carolina. By leveraging precise fabrication techniques of the semiconductor industry, Liquidia has become the4/5/2016 Morrisville, NC Save This Job
Description: Job Summary The Manager of Regulatory Operations will be responsible for the planning, scheduling and coordination of eCTD submissions in collaboration with internal team members/functional areas, partner companies and contract research organizations. He/she will5/6/2016 Redwood City, CA 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
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
Product Supply Cambridge, MA, United States We are looking for a talented Clinical Supply Manager to join our team in Cambridge! Job Responsibilities: Work closely with Clinical Operations to monitor and track clinical trial enrollment plans and actual enrollment Collaborate5/17/2016 Cambridge, MA 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
Application Deadline: May 31, 2016 Location: Schaumburg, Illinois, USA Job Summary / Overview: To provide Quality Assurance support and guidance for customer complaints received by managing the Sagent customer complaint program. Proactively support the existing quality systems5/10/2016 Schaumburg, IL Save This Job
Location: Schaumburg, Illinois, USA Key Duties & Responsibilities: Product launch coordination of activities to ensure launch occurs on schedule and within budget. Manage all information, run meetings and keep project teams informed of all product development activities (i.e.5/10/2016 Schaumburg, IL Save This Job
Job Duties Act as project lead for a cross-functional team focused on designing and developing technology for new and existing respiratory products. Collaborate with and manage input from marketing, industrial design, engineering, quality and regulatory affairs and manufacturing4/6/2016 Irvine, CA Save This Job
Reporting to the Senior Director of Chemical Development, the successful incumbent will work on all process chemistry aspects of new small molecule pharmaceuticals Responsibilities will include: Assisting in oversight of CMO activities related to technology transfer, development,5/3/2016 San Francisco, CA Save This Job
Delivery Consultant? Help Please fill in the information below and use the navigational buttons to continue. Warning: Using your browser's Back and Forward buttons may produce undesirable results. If you share a true passion for technology and enjoy working together to develop5/11/2016 Holmdel, NJ Save This Job
Please fill in the information below and use the navigational buttons to continue. Warning: Using your browser's Back and Forward buttons may produce undesirable results. If you share a true passion for technology and enjoy working together to develop solutions, share ideas,4/11/2016 Holmdel, NJ Save This Job
Job Description: The Downstream Processing group at Alder BioPharmaceuticals is seeking an organized, experienced, and highly motivated individual to develop well-characterized purification processes for pipeline antibody products. The primary responsibility of the successful4/20/2016 Bothell, WA Save This Job
Location: MBI Headquarters, Davis, CA Reports to: Vice President of Regulatory and Government Affairs Summary The Zequanox Product Manager will play a critical role in ensuring customer success and satisfaction and to accelerate the adoption of the Zequanox product. The chosen5/17/2016 Davis, CA Save This Job
Esperion?s corporate headquarters are located in Ann Arbor, MI. The Company offers a competitive salary, stock-based compensation, and a comprehensive benefits package, including 401(k) with a match and health insurance. Report to: CMO Job Summary: The Vice President of4/24/2016 Ann Arbor, MI Save This Job