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Regulatory Affairs Project Manage Jobs

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(Sr.) Regulatory Affairs Specialist

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

1/11/2016  Rockville, MD  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 Director, Regulatory Affairs

Aegerion Pharmaceuticals, Inc.

Req Id 2563 - Posted 10/27/2015 - United States - Massachusetts - Cambridge - Regulatory Affairs Job Description Return to List Working in a team environment, the Senior Director will provide regulatory oversight, support and guidance to all company functions, provide key

1/5/2016  Cambridge, MA  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

Senior Director/Vice President, Regulatory Affairs

CytomX Therapeutics

CytomX is a clinical-stage biopharmaceutical company that discovers and develops novel products for the treatment of cancer, using the probodyTM technology. Probodies are antibody-based pro-drugs which leverage tumor-specific proteases to activate antibody-based therapies. Our

2/4/2016  South San Francisco, CA  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

Director, Regulatory Affairs

Prolacta Bioscience

Job Description Job Summary As a leader, the function of Director of Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required regulations. Additionally, the

2/9/2016  City of Industry, CA  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

12/9/2015  Cambridge, MA  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

Director, Clinical Affairs

T2 Biosystems, Inc.

Stage 2: Product Development 

Tracking Code 178-093 Job Description We are seeking a bright, driven and motivated individual to join our team as Director, Clinical Affairs. This highly visible and impactful position will report directly to the Vice President, Clinical and Regulatory Affairs.

12/10/2015  Lexington, MA  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

(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

1/11/2016  Rockville, MD  Save This Job

Senior Director, Clinical Operations

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

Clinical Research Associate II

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

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

12/26/2015  Irvine, CA  Save This Job

Director, Clinical Operations

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

Delivery Consultan

Sparta Systems

If you share a true passion for technology and enjoy working together to develop solutions, share ideas, and exchange knowledge we want to talk to you. Sparta Systems is the Leader in Enterprise Quality Management Solutions (EQMS) and moving forward! As a Delivery Consultant

1/28/2016  Hamilton, NJ  Save This Job

Delivery Consultant

Sparta Systems

If you share a true passion for technology and enjoy working together to develop solutions, share ideas, and exchange knowledge we want to talk to you. Sparta Systems is the Leader in Enterprise Quality Management Solutions (EQMS) and moving forward! As a Delivery Consultant

12/29/2015  Hamilton, NJ  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

Clinical Research Associate

Penumbra, Inc.

Job opening ID10 Posting titleClinical Research Associate Roles and responsibilitiesAs a member of our clinical research team, you will participate in the execution of clinical studies to assess the safety and effectiveness of Penumbra?s products. Working with confidential

12/10/2015  Alameda, CA  Save This Job