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CMC Project Manager Jobs

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Regulatory Affairs Manager (CMC)

Alder Biopharmaceuticals

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 direct

4/20/2016  Bothell, WA  Save This Job

Regulatory Affairs Manager

Genocea Biosciences, Inc.

Position Summary The Manager of Regulatory Affairs is accountable for the preparation and management of simple and complex regulatory submissions. They will act as liaison between Regulatory Affairs and other functional areas on various projects including external CROs, partners,

5/26/2016  Cambridge, MA  Save This Job

Manager, Regulatory Operations

OncoMed Pharmaceuticals

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 will

5/6/2016  Redwood City, CA  Save This Job

Manager, Analytical Development and Quality Control

Avid Radiopharmaceuticals

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 is

5/11/2016  Philadelphia, PA  Save This Job

Manager - Regulatory Affairs

FibroGen

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

Associate Director, Regulatory Affairs

Aprecia Pharmaceuticals

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