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Director, Regulatory Affairs Jobs

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Director, Regulatory Affairs (Gaithersburg, MD)(Req# 14-100)

Vaxin

Stage 3: Beta Test / Clinical Trials 

Summary of Position The Director, Regulatory Affairs is the regulatory representative on the Product Development Teams providing regulatory support and advice. The Director will facilitate regulatory strategy development and implementation, take the lead on regulatory

10/19/2014  Gaithersburg, MD  Save This Job

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

10/21/2014  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

10/5/2014  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

11/10/2014  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-?

11/3/2014  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.

10/15/2014  Emeryville, CA  Save This Job

Director Regulatory Affairs

EnVivo Pharmaceuticals

The position is responsible for providing Regulatory Affairs direction for FORUM?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

10/20/2014  Brighton, MA  Save This Job

Medical Director - Medical Affairs (2 Positions) (036)

Relypsa

SUMMARY: The Medical Directors, 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 Medical

10/21/2014  Redwood City, CA  Save This Job

Senior Director of CMC Regulatory Affairs

EnVivo Pharmaceuticals

Provides CMC regulatory direction and strategic technical regulatory input across all programs to ensure that all CMC regulatory requirements/commitments are met with respect to development and approval of all Forum products. This is a key, new regulatory role in a rapidly

10/20/2014  Brighton, MA  Save This Job

Head, Quality Systems and Regulatory Affairs

Fluidigm Corporation

More information about this job: The right job isn?t about location or benefits or responsibilities. The right job is about personality, character, motivation, and fulfillment. It?s about what inspires us, what we?re passionate about. At Fluidigm, we?re passionate about life.

9/22/2014  South San Francisco, CA  Save This Job

Director, Clinical Affairs

Singulex

Executive Summary: The Director/Sr. Direcor of Clinical Affairs, will be responsible for managing the functional organization and execution of clinical trials (registration, pre-registration, post-registration, and marketing studies) in support of company products either through

10/28/2014  Alameda, CA  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

Medical Director - Clinical Development (2 Positions) (038)

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

10/21/2014  Redwood City, 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

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

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

Director, Global Alliance Management

Sagent Pharmaceuticals

Department: Global Alliance Management Reports To: Vice President, Global Alliance Management Job Summary / Overview: This position is responsible for overseeing the execution of all product development activities from initiation of the project through product launch

11/18/2014  Schaumburg, IL  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

10/26/2014  Fremont, CA  Save This Job

Associate Medical Director - Medical/Clinical Affairs

ChemoCentryx, Inc.

This Associate Medical Director level position requires the ability to work with supervision, in responsibilities associated with all aspects of design, setup, monitoring, and analysis of Phase 1 - 3 clinical trials. This person must have the ability to interact effectively with

10/5/2014  Mountain View, CA  Save This Job

Executive Director, Drug Safety and Pharmacovigilance (054)

Relypsa

SUMMARY: Reporting to the Chief Medical Officer, the Executive Director will serve as the Head of Drug Safety and Pharmacovigilance (PV) Department and will have primary responsibility for the operational and strategic assessment of safety information and the implementation of

10/21/2014  Redwood City, CA  Save This Job