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Regulatory Affairs Manager Jobs

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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

7/31/2016  Bothell, WA  Save This Job

Regulatory Affairs Manager

Alder Biopharmaceuticals

The responsibilities of this newly created position will focus on supporting the development and implementation of regulatory strategies for Alder BioPharmaceuticals development programs. This includes responsibility for preparation and submission of regulatory documentation to

8/30/2016  Bothell, WA  Save This Job

Manager - Regulatory Affairs

Sciformix Corporation

Manager - Regulatory Affairs (United States; Russia; Egypt; Turkey; UAE; Israel; Saudi Arabia) Responsibilities Manager positions will be responsible for administering the day-to-day Regulatory Affairs operations. Responsibilities may include: Directly or indirectly managing

8/23/2016  Westborough, MA  Save This Job

Regulatory Affairs Specialist (U.S.)

Globus Medical

Location:Audubon, PA Job Code:RAPMKB0515 Description The Regulatory Affairs Specialist assists in writing, submitting and gaining clearance for 510(k) submissions and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products.

8/29/2016  Audubon, PA  Save This Job

Senior Associate Regulatory Affairs - Post Approval/Annual Reporting

Sagent Pharmaceuticals

Application Deadline: September 30, 2016 Location: Schaumburg, IL Job Summary / Overview: Responsible for the support of Post approval regulatory affairs activities as directed by the Senior Manager which may include: Annual reports, supplements, change controls, labeling,

9/22/2016  Schaumburg, IL  Save This Job

Medical Director, Regulatory Affairs

Sagent Pharmaceuticals

Application Deadline: August 31, 2016 Location: Schaumburg, IL Job Summary / Overview: In the capacity of Medical expert, the Medical Director is responsible for bringing greater medico-clinical based product insights to the organization. In addition, this role provides greater

8/23/2016  Schaumburg, IL  Save This Job

Group Manager, Regulatory Affairs

Globus Medical

Location:Audubon, PA Job Code:GMRALB0816 Description The Group Manager, US Regulatory, is responsible for preparing, filing and gaining approval of 510(k), IDE, and PMA submissions to the U.S. Food and Drug Administration (FDA) for class II and class III products. This position

8/29/2016  Audubon, PA  Save This Job

Program Manager, Surgeon Education and Training

Globus Medical

Location:Audubon, PA Job Code:PMSEJL0816 Description The Program Manager is responsible for the strategic plan development and tactical execution of medical education programs for assigned business segment(s). Responsible for the creation, implementation, promotion and

8/29/2016  Audubon, PA  Save This Job

Sr. Clinical Supply Manager

Merrimack Pharmaceuticals

Clinical Operations Cambridge, MA, United States Merrimack is a fully integrated biopharmaceutical company that views cancer as a complex engineering challenge. Through systems biology, which brings together the fields of biology, computing and engineering, Merrimack aims to

8/28/2016  Cambridge, MA  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?

8/1/2016  Boston, MA  Save This Job

Manager, Regulatory Operations

OncoMed Pharmaceuticals

Description: Job Summary The Manager of Regulatory Operations will be responsible for the planning, scheduling and coordination of eCTD submissions in collaboration with internal team members/functional areas, partner companies and contract research organizations. He/she will

8/17/2016  Redwood City, CA  Save This Job

Senior Manager/Associate Director, Pharmaceutical Development

ChemoCentryx, Inc.

Working with CCXI Senior Management, Contract Development Organizations and selected Consultants, this individual is responsible for the development and overseeing the execution of all the technical activities associated with product development in support of Clinical Development

9/8/2016  Mountain View, CA  Save This Job

Senior Manager, GCP Compliance

Alder Biopharmaceuticals

This newly created position reports to the Director, Quality Assurance Compliance and is responsible for assuring GCP compliance with Alder SOPs, ICH and FDA/EMA regulations. Specific responsibilities will include: Provide GCP compliance support: participate in Clinical Project

7/31/2016  Bothell, WA  Save This Job

Zequanox Product Manager

Marrone Organic Innovations

Location: MBI Headquarters, Davis, CA Reports to: Vice President of Regulatory and Government Affairs Summary The Zequanox Product Manager will play a critical role in ensuring customer success and satisfaction and to accelerate the adoption of the Zequanox product. The chosen

8/29/2016  Davis, CA  Save This Job

Manager - GCP Quality Assurance

Argos Therapeutics

Manager ? GCP Quality Assurance About Us Manager ? GCP Quality Assurance Description Argos Therapeutics is a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases

8/15/2016  Durham, NC  Save This Job

Manager, Educational Affairs

Cleveland HeartLab

CLEVELAND HEARTLAB SEPTEMBER 9, 2016 JOB OPENINGS 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

9/27/2016  Cleveland, OH  Save This Job

Senior Project Manager

Alder Biopharmaceuticals

This newly created position will work closely with the VP Program & Portfolio Management (PM) to provide specialized cross-functional PM leadership for Alder?s drug development programs through expert planning, risk mitigation and execution. Collaborates with functional project

7/31/2016  Bothell, WA  Save This Job

Director, Quality Systems

Sagent Pharmaceuticals

Application Deadline: October 31, 2016 Location: Schaumburg, Illinois, United States Job Summary: Leads the Quality Systems team and provides guidance and direction to all after-market Sagent product quality issues. Partners with Sagent?s Global Alliance Management

9/22/2016  Schaumburg, IL  Save This Job