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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 direct4/20/2016 Bothell, WA 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
Department: CMC (Analytical Development and Quality Control) Job Title: Manager, Analytical Development and Quality Control Reports To: Senior Director, Analytical Development and Quality Control Description: The Manager of Analytical Development and Quality Control is5/11/2016 Philadelphia, PA 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
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