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Regulatory Affairs Project Manager Jobs

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Regulatory Affairs Project Manager

Globus Medical

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 class

4/17/2016  Audubon, PA  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

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

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 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

International Regulatory Project Manager

Globus Medical

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 with

4/17/2016  Audubon, PA  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

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

Clinical Supply Manager

Merrimack Pharmaceuticals

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 Collaborate

5/17/2016  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

Zequanox Product Manager

Marrone Organic Innovations

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 chosen

5/17/2016  Davis, CA  Save This Job

Manager, Medical Information

Relypsa

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. The

4/12/2016  Redwood City, CA  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

Quality Assurance Complaint Specialist

Sagent Pharmaceuticals

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 systems

5/10/2016  Schaumburg, IL  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