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Director, Regulatory Affairs Jobs

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Director/Senior Director, Regulatory Affairs

Merrimack Pharmaceuticals

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 underlying cancer biology through its systems

1/12/2015  Cambridge, MA  Save This Job

Director / Associate Director Regulatory Affairs

Catabasis

Catabasis Pharmaceuticals, Inc. is dedicated to the discovery and development of innovative, effective and safe medicines to treat inflammatory and metabolic diseases. We are assembling a team of highly motivated and experienced professionals who are committed to improving the

1/27/2015  Cambridge, MA  Save This Job

Director, Regulatory Affairs (14-175)

FibroGen

Description: Reporting to the Vice President of Regulatory Affairs, the successful candidate will provide expertise in translating regulatory requirements into practical, workable plans for development stage oncology related drugs and biologics. Candidate will have primary

12/28/2014  San Francisco, CA  Save This Job

Director, Regulatory Affairs

Acceleron Pharma

About Acceleron: Acceleron is a publicly traded, 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 TGF-?

1/27/2015  Cambridge, MA  Save This Job

Medical Director & Regulatory Affairs

Milagen

We are seeking a highly experienced candidate with an advanced medical and science degree, preferably in oncology, to lead our effort into the clinical development of the company immunodiagnostic assay pipeline, and provide strategic guidance in regulatory affairs and compliance.

1/3/2015  Emeryville, CA  Save This Job

Director/Senior Director, Regulatory Affairs

Dicerna Pharmaceuticals

Company Description: Dicerna Pharmaceuticals is a biopharmaceutical company focused on the discovery and development of innovative treatments for rare inherited diseases involving the liver and for cancers that are genetically defined. Dicerna?s entire drug pipeline is generated

1/25/2015  Watertown, MA  Save This Job

Senior Associate, Regulatory Affairs CMC (14-466)

MacroGenics

Job Code: 14-466 Location: Rockville, MD Applicants must meet the following requirements: Bachelor?s Degree in a scientific discipline; advanced degree desirable, especially in Regulatory Science Regulatory Affairs Certification (RAC) preferred Minimum 3 years in a Regulatory

1/26/2015  Rockville, MD  Save This Job

Regulatory Affairs Specialist II

GlycoMimetics

Reports to: Director, Regulatory Affairs and Quality Assurance Job Code: 2015-70-2 Job Summary The Regulatory Affairs Specialist II will provide support and knowledge to the regulatory affairs department. S/he will coordinate and prepare packages for regulatory submission.

3/2/2015  Gaithersburg, MD  Save This Job

Director of Regulatory Affairs and Quality Assurance

ABT Molecular

Job Description The Director of Regulatory Affairs and Quality Assurance (Director of RA/QA) is the ABT functional expert responsible for drug regulatory and device quality assurance thereby controlling the efforts and process of ABT ensuring control, efficiency, documentation,

2/11/2015  Louisville, TN  Save This Job

Senior/Executive Director, Medical Affairs

Aegerion Pharmaceuticals, Inc.

Reporting into the Vice President of Medical Affairs, the Senior/Executive Director will be part of the Medical Affairs organization at Aegerion headquarters in Cambridge and will contribute to the medical/clinical output from that team. A key part of this role will be to serve

1/14/2015  Cambridge, MA  Save This Job

Regulatory Affairs Manager

CardioFocus

Department:Regulatory, Clinical and Quality Job Reports To:Director, Quality Assurance & Regulatory Compliance FLSA:Exempt POSITION OVERVIEW Job Purpose: The Regulatory Affairs Manager facilitates the initial approval and continued regulatory support necessary CardioFocus

1/13/2015  Marlborough, MA  Save This Job

Director Quality and Regulatory Affairs

CAPNIA

JOB SUMMARY This position is responsible for quality and regulatory aspects related to the design, development, manufacturing, registration and commercialization of Capnia?s products. This position works in a team environment, interacting with all departments throughout the

1/5/2015  Redwood City, CA  Save This Job

Medical Director - Medical Affair

Relypsa

Position Overview The Medical Director, Medical Affairs, will lead a broad range of medical affairs activities to plan for and support the launch of patiromer. Reporting to the VP, Medical Affairs and working closely with both the Commercial and Clinical Development groups, the

2/5/2015  Redwood City, CA  Save This Job

Director, Project Management

Cytokinetics

Department: Project Management Job Title: Director, Project Management Job Location: South San Francisco Description: Cytokinetics, Inc. is a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics that modulate

1/29/2015  South San Francisco, CA  Save This Job

Director, Quality Assurance

Ambit Biosciences

Department: Regulatory Affairs Job Title: Director, Quality Assurance Job Location: San Diego, CA Description: The Director, Quality Assurance is responsible for the strategic leadership and guidance of QA functions with a focus on GMP, GCP, and GLP activities. Additionally,

2/2/2015  San Diego, CA  Save This Job

Medical Director - Clinical Development

Relypsa

SUMMARY: The core focus for the appointee will be both the strategic and tactical execution of new clinical trials for patiromer and/or the development and execution of a clinical development plan to support a European MAA and to support a pediatric indication. Ideally, the

1/6/2015  Redwood City, CA  Save This Job

Associate Director Analytical Chemistry

Aegerion Pharmaceuticals, Inc.

We are seeking an accomplished analytical chemist with experience in both small and biological molecule analytical method development, validation, and transfer working with external manufacturing organizations. Experience with both drug substance and drug product analyses at

1/14/2015  Cambridge, MA  Save This Job

Director, Pharmaceutical Development

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

2/5/2015  Redwood City, CA  Save This Job

Validation Manager/Director

Protein Sciences

Job Description This position is responsible for facilitating oversight, evaluation and performance of all equipment, facilities, systems, utilities and product/process validation for Protein Sciences Corp. The encumbant will be the SME (subject matter expert) and help

1/27/2015  Meriden, CT  Save This Job

Director of Project Management (2014-04)

Zosano Pharma

Job code: 2014-04 Zosano Pharma, Inc. is a specialty pharmaceutical company creating better products utilizing innovative drug delivery technology. We have developed a user-friendly, simple, and needle-free transdermal delivery system consisting of a patch and applicator ? that

1/11/2015  Fremont, CA  Save This Job