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

10/27/2015  Audubon, PA  Save This Job

Manager, Regulatory Affairs, Labeling

Sagent Pharmaceuticals

Location: Schaumburg, Illinois, USA Job Title: Manager, Regulatory Affairs (Labeling) Department: Regulatory Affairs Reports To: Sr. Manager, Regulatory Affairs AND/OR Director Regulatory Affairs Job Summary / Overview: This role is primarily responsible for independently

11/18/2015  Schaumburg, IL  Save This Job

Manager, Regulatory Affairs

Aprecia Pharmaceuticals

Job ID88 Overview Responsible for the development, review, and submission of regulatory filings (e.g. Annual Reports, Supplements, CBEs (Changes Being Effected), Protocols, etc.), tracking and updating status reports, and supporting Regulatory Affairs senior management in all

10/10/2015  Blue Ash, OH  Save This Job

Regulatory Affairs Manager or Sr. Manager


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

11/3/2015  Rockville, MD  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

10/26/2015  Bothell, WA  Save This Job

Senior Project Manager

Good Start Genetics

Other Cambridge, MA, United States Good Start Genetics is a molecular genetics information company transforming the standard of care in reproductive medicine. Its suite of reproductive genetics products provides clinicians and patients with insightful and actionable information

11/2/2015  Cambridge, MA  Save This Job

Manager/Director, Regulatory Affairs


JOB DESCRIPTION GENERAL INFORMATION Position Title: Manager/Director, Regulatory Affairs Department: Regulatory Reports to: Vice President, Regulatory & QA FLSA Status: Exempt Version: 7/24/15 PURPOSE OF THE JOB Manage and direct the company?s global regulatory submissions

10/26/2015  Fremont, CA  Save This Job

Clinical Project Manager (Clinical Trials)


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

10/21/2015  Redwood City, CA  Save This Job

Associate Director, Project Management


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

11/20/2015  Redwood City, CA  Save This Job

Clinical Supply Manager

Merrimack Pharmaceuticals

Product Supply Cambridge, MA, United States Merrimack is a biopharmaceutical company discovering, developing and preparing to commercialize innovative medicines paired with companion diagnostics for the treatment of cancer. Merrimack seeks to gain a deeper understanding of

10/26/2015  Cambridge, MA  Save This Job


Esperion Therapeutics Inc.

Position Summary: Establishes and monitors the global Clinical Supplies strategy for protocol development at the study level Ensure appropriate processes are established and implemented to ensure clinical supplies and key deliverables for each study within the program are

9/28/2015  Ann Arbor, MI  Save This Job

Manager, Clinical Operations

Acceleron Pharma

About Acceleron: Acceleron is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of novel protein therapeutics for cancer and rare diseases. The company is a leader in understanding the biology of the Transforming Growth

10/5/2015  Cambridge, MA  Save This Job

Exec/Sr. Director, Project Management

Zogenix, Inc.

Department: Clinical Development Location: Emeryville, CA Position Summary Zogenix is currently seeking a senior Project Management Professional experienced in Pharmaceutical Drug Product Development, to lead the project management function at Zogenix including direct

9/27/2015  Emeryville, CA  Save This Job

EH&S Coordinator


Supervisor?s Title Agri Energy General Manager Division Regulatory Affairs/EH&S Band Level Applying Level OVERALL PURPOSE OF POSITION NOTE: This section should include one or two sentences, which describe the overall purpose of this job ? why does it exist and what are its

10/24/2015  Englewood, CO  Save This Job

Manufacturing Specialist

Tactile Systems Technology

Department: Manufacturing Operations Reports to: Director of Operations and Project Management Scope of Supervision: No Direct Reports EDUCATION, BUSINESS EXPERIENCE, AND PHYSICAL REQUIREMENTS ? Basic computer skills necessary ? Experience in medical device assembly, and working

9/29/2015  Minneapolis, MN  Save This Job