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Director, Regulatory Affairs Jobs

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Senior Manager / Director, Regulatory Affairs

FirstFuel Software

More information about this job: Overview: Senior Manager / Director, Regulatory Affairs Job Code: 14REG.007 Location: Lexington, MA Due to the continued growth of FirstFuel, and in particular in the Northeast and Midwest Regions, added regulatory leadership is needed to gain

4/23/2014  Lexington, MA  Save This Job

Director, Regulatory Affairs, Global CMC

Aegerion Pharmaceuticals, Inc.

Position Description The Director, Regulatory Affairs, Global CMC will report to the Chief Regulatory Officer and be responsible for the development of global Chemistry, Manufacturing and Control (CMC) regulatory strategy for investigational and marketed products and manage

2/22/2014  Cambridge, MA  Save This Job

Associate Director/Director Regulatory Affairs

Cytokinetics

Description: Cytokinetics, Inc. is a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel small molecule therapeutics that modulate muscle function for the potential treatment of serious diseases and medical conditions. Working

4/18/2014  South San Francisco, CA  Save This Job

Senior Director, Regulatory Affairs

Merrimack Pharmaceuticals

Merrimack Pharmaceuticals is a biopharmaceutical company discovering, developing and preparing to commercialize innovative medicines paired with companion diagnostics for the treatment of serious diseases, with an initial focus on cancer. Merrimack currently has six targeted

3/11/2014  Cambridge, MA  Save This Job

Assoc./ Director, Regulatory affairs

Avanir Pharmaceuticals

POSITION DETAILS POSITION SUMMARY The Regulatory Affairs team supports Avanir throughout the product development and commercial life cycle by interacting with regulatory agencies,facilitating regulatory activities, preparing regulatory documentation and coordinating

3/31/2014  Aliso Viejo, CA  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.

3/23/2014  Emeryville, CA  Save This Job

Director Regulatory Affairs

EnVivo Pharmaceuticals

The position is responsible for providing Regulatory Affairs direction for EnVivo?s products. They will author, review and edit regulatory submissions, develop regulatory strategy in conjunction with business objectives and functional management, and drive timelines and

3/25/2014  Watertown, MA  Save This Job

Director, Regulatory Affairs

Tetraphase Pharmaceuticals

Job Description: Tetraphase Pharmaceuticals seeks a motivated and team-oriented individual who will be a key contributor to our regulatory activities and management of regulatory policy and practice. The successful candidate will report to the CEO as well as work closely and

2/24/2014  Watertown, MA  Save This Job

Sr Manager, Regulatory Affairs

Sagent Pharmaceuticals

Sr Manager, Regulatory Affairs Department: Regulatory Affairs Classification: Exempt Reports To: Sr. Director, Regulatory Affairs Job Summary / Overview: Serves as the primary regulatory interface with FDA, Partners and internal team. Ensure the business needs for the

4/24/2014  Schaumburg, IL  Save This Job

Sr Associate II, Regulatory Affairs

Sagent Pharmaceuticals

Department: Regulatory Affairs Reports To: Associate Director, Regulatory Affairs Job Summary / Overview: Responsible for the support of Pre and Post approval regulatory affairs activities as directed by the Manager and Senior Manager which may include: Drug listing,

4/24/2014  Schaumburg, IL  Save This Job

Director of Regulatory Affairs

Zogenix, Inc.

Position Summary This Director, Regulatory Affairs is responsible for providing strategic and operational leadership in the area of the Risk Evaluation and Mitigation Strategy (REMS) for Zogenix products. This individual will ensure that Zogenix is in compliance with all

2/23/2014  Emeryville, CA  Save This Job

Director/Manager, Regulatory Affairs

Merrimack Pharmaceuticals

Merrimack Pharmaceuticals is a biopharmaceutical company discovering, developing and preparing to commercialize innovative medicines paired with companion diagnostics for the treatment of serious diseases, with an initial focus on cancer. Merrimack currently has six targeted

3/11/2014  Cambridge, MA  Save This Job

Senior Manager, Regulatory Affairs, Labeling

Sagent Pharmaceuticals

Job Title: Senior Manager, Regulatory Affairs, Labeling Department: Regulatory Affairs Reports To: Regulatory Affairs Associate Director Classification: Exempt Basic Function: Responsible for coordinating labeling activities with our partners and supervising

4/24/2014  Schaumburg, IL  Save This Job

Associate/Senior Associate Regulatory Affairs

Putney

Description Putney is a pharmaceutical company based in Portland, ME which specializes in providing high quality generic drugs for pets where cost is a barrier to prescribing, compliance or use. Putney's current pipeline includes orals, injectables, liquids and semi-solid

4/22/2014  Portland, ME  Save This Job

Director of Regulatory Affairs & Quality Assurance

Zonare Medical Systems

Reports To: Vice President, Operations Job Summary The Director of Regulatory Affairs and Quality Assurance is responsible for all aspects of the regulatory and quality activities at ZONARE Medical Systems. The Director is responsible for developing strategies for worldwide

3/20/2014  Mountain View, CA  Save This Job

Director Medical Affairs - Psychiatry (MD)

EnVivo Pharmaceuticals

EnVivo is announcing an opportunity for Director of Medical Affairs, Psychiatry. The Director of Medical Affairs will lead the development and execution of the Medical Plan and be a lead medical contributor to overall brand planning and pre-launch/launch strategy for potential

3/25/2014  Watertown, MA  Save This Job

Senior Director/Executive Director, Medical and Clinical Affairs

Durata Therapeutics, Inc.

POSITION DESCRIPTION: This Senior Director/Executive Director, Medical and Clinical Affairs will be responsible for managing projects within clinical development that lead to successful registration and approval of pipeline projects. In addition, this role will engage the

3/3/2014  Branford, CT  Save This Job

Director, Product Development

Zogenix, Inc.

Position Summary The Director of Product Development will be responsible for planning, implementing and managing product development, including delivery system characterization, activities for new drug product development at Zogenix through contract development laboratories,

2/23/2014  Emeryville, 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

3/19/2014  South San Francisco, CA  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

3/27/2014  Fremont, CA  Save This Job