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Regulatory Affairs Project Manage Jobs

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SENIOR DIRECTOR OF REGULATORY AFFAIRS

Zeltiq Aesthetics, Inc.

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

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

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

Vice President of Regulatory Affairs

Genocea Biosciences, Inc.

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-stage

3/23/2016  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

Executive Director, Regulatory Affairs

Liquidia Technologies

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 the

4/5/2016  Morrisville, NC  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

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

Medical Writer or Sr. Medical Writer

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

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

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, Global Alliance Management

Sagent Pharmaceuticals

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

Senior Mechanical Engineer

Breathe Technologies

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 manufacturing

4/6/2016  Irvine, CA  Save This Job

Senior Director of Chemical Development

FibroGen

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

Sparta Systems

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 develop

5/11/2016  Holmdel, NJ  Save This Job

Delivery Consultant

Sparta Systems

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

Scientist/Senior Scientist, Downstream Processing

Alder Biopharmaceuticals

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 successful

4/20/2016  Bothell, WA  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

VP CLINICAL DEVELOPMENT

Esperion Therapeutics Inc.

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 of

4/24/2016  Ann Arbor, MI  Save This Job