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Director of Regulatory Affairs Jobs

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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

6/15/2015  Cambridge, MA  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-?

6/20/2015  Cambridge, MA  Save This Job

Director, Regulatory Affairs (15-136)

FibroGen

Job Location: San Francisco, CA Description: Reporting to the Vice President of Regulatory Affairs, the successful candidate will provide leadership in assuring compliance in regulatory requirements for successful drug development. Candidate will have primary responsibility for

6/24/2015  San Francisco, CA  Save This Job

Manager, Regulatory Affairs

Sagent Pharmaceuticals

Location: Schaumburg, IL, USA Manager, Regulatory Affairs Department: Regulatory Affairs Reports To: Sr Manager, Regulatory Affairs AND/OR Associate Director Regulatory Affairs Job Summary / Overview: The role is primarily responsible for the management and support of Pre

5/27/2015  Schaumburg, IL  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.

6/30/2015  Emeryville, CA  Save This Job

Director of Drug Safety Operations

KaloBios Pharmaceuticals

Department: Clinical Operations Job Location: South San Francisco, CA The Director of Drug Safety Operations will have primary responsibility for the following: Responsible for the operational management and oversight of case processing, end-to-end, activities performed

7/24/2015  South San Francisco, CA  Save This Job

Manager, Regulatory Affairs

GlycoMimetics

Reports to: Senior Director, Regulatory Affairs and Quality Assurance Job Code: 2015 -70 -5 Job Summary The Manager, Regulatory Affairs contributes to and implements regulatory strategies, prepares US and rest of world (ROW) regulatory submissions, and maintains the regulatory

6/22/2015  Gaithersburg, MD  Save This Job

Director, Analytical Sciences

OncoMed Pharmaceuticals

Description: Job Summary The successful candidate for Director will be responsible for managing the Analytical Sciences group. Key responsibilities of the group are methods development, qualification and technology transfer activities, protein characterization, and analytical

6/29/2015  Redwood City, CA  Save This Job

Associate Director / Director, Analytical and Quality Control

Verastem

Strong background and experience in Analytical method development and validation activities for full characterization of a small molecule NCE Work with CMO?s / CRO?s to carry out analytical development and validation activities to enable characterization, release testing and

6/20/2015  Needham, MA  Save This Job

Medical Director - Clinical 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

5/31/2015  Redwood City, CA  Save This Job

Director, Medical Research

Acceleron Pharma

Director, Medical Research (MD or MD/Ph.D) 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

7/20/2015  Cambridge, MA  Save This Job

Associate Medical Director - Drug Safety Physician

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

6/30/2015  Redwood City, CA  Save This Job

Senior Medical Director, Clinical Development

Aegerion Pharmaceuticals, Inc.

Position Description Aegerion is seeking a Senior Medical Director of Clinical Development who will develop, lead, and drive the clinical development and regulatory strategy of Metreleptin, a key program at Aegerion. As a newly acquired asset, Metreleptin is in its early stages

6/7/2015  Cambridge, MA  Save This Job

Senior Director, Global Training

Aegerion Pharmaceuticals, Inc.

Lead the strategy and execution, of a developing world class Global Training and Sales Force function. Establish clearly defined objectives, strategies, tactics, and action plans. Establish and continuously improve, in partnership with colleagues in sales, marketing, medical

6/7/2015  Cambridge, MA  Save This Job

Quality Assurance Specialist, Change Control

Sagent Pharmaceuticals

Location: Schaumburg, IL, USA Department: Quality Assurance & Facility Compliance Reports To: Senior Director Quality Assurance Job Summary / Overview: Responsible for the support and approval of change controls for all internal, labeling and external changes involving our

5/27/2015  Schaumburg, IL  Save This Job

Senior Manager, Pharmaceutical Process Development and Clinical Manufacturing

GlycoMimetics

Reports to: Senior Director, Manufacturing and Non-Clinical Operations Job Code: 2015 -70-4 Job Summary The Senior Manager, Pharmaceutical Process Development and Clinical Manufacturing manages the transfer and scale-up of synthetic chemical processes and sterile drug product

6/22/2015  Gaithersburg, MD  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

6/14/2015  Minneapolis, MN  Save This Job

QUALITY ASSURANCE ENGINEER

ViewRay

Reports to Sr. Director, Regulatory Affairs and Quality Systems Responsibilities Oversees NCR and SCAR activities for ViewRay Works closely with engineering to document CA and PA as appropriate Audits Level 1 suppliers when necessary Monitors and trends supplier performance ?

6/29/2015  Mountain View, CA  Save This Job

Clinical Research Project Manager

Globus Medical

Location:Audubon, PA Job Code:CRPMGJ0415 Description The Project Manager, Clinical Research will be responsible for conducting post marketing clinical research on Globus Medical products. The candidate should have demonstrated abilities to conduct clinical trials and work with

6/7/2015  Audubon, PA  Save This Job