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Senior Manager, Regulatory Affairs Jobs

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Senior Manager, Regulatory Affairs

Relypsa

Company Overview Relypsa, Inc. is a late clinical-stage pharmaceutical company leading the discovery and development of novel non-absorbed polymeric drugs for important applications in cardiovascular and renal diseases. Relypsa's lead product candidate is patiromer, a

4/12/2016  Redwood City, CA  Save This Job

Senior Associate, Regulatory Affairs

Sagent Pharmaceuticals

Location: Schaumburg, Illinois, USA Senior Associate, Regulatory Affairs Reports To: Senior Manager, Regulatory Affairs Job Summary / Overview: Responsible for the support of Pre and Post approval regulatory affairs activities as directed by the Senior Manager which may

4/10/2016  Schaumburg, IL  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

MANAGER, FP&A: CLINICAL RESEARCH & DEVELOPMENT, REGULATORY AFFAIRS &

Cytokinetics

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 muscle

4/5/2016  South San Francisco, CA  Save This Job

Regulatory Affairs Manager or Sr. Manager

MacroGenics

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 with

3/27/2016  Rockville, MD  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

Clinical Trial Manager

Promedior

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?

4/23/2016  Boston, MA  Save This Job

Senior Project Manager

Alder Biopharmaceuticals

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 project

5/20/2016  Bothell, WA  Save This Job

TECHNICAL WRITER

ViewRay

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 Product

5/5/2016  Mountain View, CA  Save This Job

Director of Clinical Operations

Argos Therapeutics

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 novel

4/4/2016  Durham, NC  Save This Job