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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

12/30/2015  Redwood City, CA  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

12/28/2015  Schaumburg, IL  Save This Job

Senior Manager, Regulatory Affairs (Operations) (2742)

Aegerion Pharmaceuticals, Inc.

Req Id 2742 - Posted 12/23/2015 - United States - Massachusetts - Cambridge - Regulatory Affairs Job Description Print Preview The Senior Manager, Regulatory Affairs (Operations) will be responsible for overseeing operational aspects of all Aegerion regulatory submissions,

2/4/2016  Cambridge, MA  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

1/27/2016  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,

12/22/2015  Blue Ash, OH  Save This Job

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

1/5/2016  Audubon, PA  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

12/12/2015  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

12/5/2015  Bothell, WA  Save This Job

Manager/Director, Regulatory Affairs

Ardelyx

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

1/4/2016  Fremont, CA  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?

12/7/2015  Boston, MA  Save This Job

Senior Quality Assurance Audit Manager (2903)

Aegerion Pharmaceuticals, Inc.

Req Id 2903 - Posted 12/23/2015 - United States - Massachusetts - Cambridge - Regulatory Affairs Job Description Print Preview Apply Apply using LinkedIn? Save Job Email Job to Friend Return to List The Senior Quality Assurance Audit Manager is responsible for oversight

1/5/2016  Cambridge, MA  Save This Job

Clinical Trial Manager

Acceleron Pharma

About Acceleron: Acceleron is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutic candidates that regulate cellular growth and repair. The company is a leader in understanding the biology of the

12/13/2015  Cambridge, MA  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

12/13/2015  Cambridge, MA  Save This Job

Director of Quality Assurance and Regulatory Affair

TeraRecon

Location:USA - CA Company Order Number:397 # of openings:1 Description About the Company TeraRecon is the largest independent, vendor neutral medical image viewing solution provider with a focus on advanced image processing innovation. TeraRecon iNtuition and iNteract+

1/4/2016  San Mateo, CA  Save This Job

Clinical Operations Manager

Regenesis Biomedical

Job Details Level Experienced Job Location USA-AZ-Scottsdale Position Type Full Time Job Shift Day Education Level 4 Year Degree Job Category Research Description POSITION SUMMARY The Clinical Operations Manager plays an essential role in the development and implementation of

12/26/2015  Scottsdale, AZ  Save This Job

Clinical Project Manager II (Clinical Trials)

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

12/30/2015  Redwood City, CA  Save This Job