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Regulatory Affairs Manager Jobs

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CMC Regulatory Affairs Manager

Argos Therapeutics

ARGOS IS GROWING! After having met several important milestones including exciting clinical data, we are poised for new strategic objectives which will require significant new resources. Those new resources include a well-qualified CMC Regulatory Affairs Manager. SCOPE: Serves

11/11/2014  Durham, NC  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

11/26/2014  Marlborough, MA  Save This Job

Regulatory Affairs Manager (14-608)

MacroGenics

Job Code: 14-608 Location: Rockville, MD Applicants must meet the following requirements: Minimum of Bachelor?s degree in scientific discipline; advanced degree desirable Minimum of 4 years of Regulatory Affairs experience (at least 2 years working in a Regulatory Affairs

11/3/2014  Rockville, MD  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

10/28/2014  Audubon, PA  Save This Job

Senior Associate/Manager Regulatory Affairs

OncoMed Pharmaceuticals

Description: Job Summary The Senior Associate/Manager will plan, prepare and submit to FDA and other appropriate Health Authorities (in collaboration with internal team members/functional areas, partner companies and contract research organizations) varied regulatory filings and

11/13/2014  Redwood City, CA  Save This Job

International Regulatory Project Manager

Globus Medical

Description The International Project Manager writes, submits and gains approval of product registrations and other submissions to international Regulatory agencies. This position entails development of submissions in conjunction with other Globus departments, requiring working

10/28/2014  Audubon, PA  Save This Job

Head of Reg. Affairs & QA

Ambit Biosciences

Department: Regulatory Affairs Job Title: Head of Reg. Affairs & QA Job Location: San Diego, CA Description: The Head of Regulatory Affairs and Quality Assurance will be responsible for leading and directing all regulatory and quality activities for Ambit Biosciences. They

10/18/2014  San Diego, CA  Save This Job

Clincial Trial Manager/Senior Manager (Oncology)

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 TGF-? protein

11/3/2014  Cambridge, MA  Save This Job

Clinical Trial Manager (Non-Oncology)

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---

11/3/2014  Cambridge, MA  Save This Job

Senior Manager/Associate Director, Pharmaceutical Development (056)

Relypsa

SUMMARY: Senior Manager/Associate Director, Pharmaceutical Development is responsible for the design, development and optimization of formulation and process for drug candidates to support the manufacture of pre-clinical, clinical, registration and commercial manufacturing. The

10/21/2014  Santa Clara, CA  Save This Job

Manager, Quality Assurance

GlycoMimetics

Reports to Director, Regulatory Affairs and Quality Assurance Job Code 2014-900 Job Summary The Manager, Quality Assurance ensures the development, implementation, and maintenance of quality assurance systems and activities. Assures that Quality Systems are managed and

10/13/2014  Gaithersburg, MD  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

10/5/2014  Meriden, CT  Save This Job

Clinical Program Manager

KaloBios Pharmaceuticals

Department: Clinical Operations Job Location: San Francisco, CA The Clinical Program Manager will be responsible for the day-to-day management of Phase I-III clinical studies. The position is pivotal to ensuring that clinical programs are executed with compliance to clinical

11/10/2014  San Francisco, CA  Save This Job

Manager, Pharmacovigilance

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 TGF--- protein

11/3/2014  Cambridge, MA  Save This Job

Medical Devices Quality Assurance Manager - FDA

Cleveland HeartLab

Cleveland HeartLab, Inc. (CHL) is a premier next-generation clinical reference laboratory committed to advancing cardiovascular risk assessment through unique and proprietary diagnostic tests. We focus on novel inflammatory and cardiovascular biomarker technologies that allow for

10/26/2014  Cleveland, OH  Save This Job

Product Specialist

Tactile Systems Technology

Department: Sales Reporting Relationship: Regional Sales Manager Scope of Supervision: Not applicable Other Key Relationships: Marketing, Product Strategy, Regulatory Affairs, Reimbursement Operations, Payer Relations, Clinical Specialists, Patients, Physicians,

9/30/2014  Minneapolis, MN  Save This Job

EH&S Coordinator

Gevo

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

10/26/2014  Luverne, MN  Save This Job

Director*, Drug Safety

Cytokinetics

Department: Regulatory Affairs Job Title: Director-, Drug Safety Job Location: Operations Description: Cytokinetics, Inc. is a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics that modulate muscle function

10/14/2014  South San Francisco, CA  Save This Job

Associate Director, Project Management

Cytokinetics

Department: Project Management Job Title: Associate 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

10/14/2014  South San Francisco, CA  Save This Job

Clinical Data Monitor

Globus Medical

Description Clinical Data Monitor The position is responsible for performing monitoring activities associated with all ongoing Class III FDA-related clinical studies. This individual will need to perform site monitoring visits by adhering to the schedule established in

10/28/2014  Audubon, PA  Save This Job