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Manager Regulatory Affairs Jobs

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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

2/2/2015  Redwood City, CA  Save This Job

Manager, Regulatory Affairs

Aegerion Pharmaceuticals, Inc.

Manages, evaluates and completes regulatory projects consistent with the company goals. Responsible for timely planning and coordination of regulatory submissions. Provides guidance to cross-functional teams on regulatory strategy and tactic With minimal supervision, plan and

2/13/2015  Cambridge, MA  Save This Job

Regulatory Affairs Associate

Aegerion Pharmaceuticals, Inc.

Reporting to the Manager, Regulatory Affairs, this position will provide regulatory operations expertise on assigned programs, and will be responsible for specific pieces of moderately complex projects. The associate would be working as a member of a small team focused on orphan

2/13/2015  Cambridge, MA  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

1/13/2015  Audubon, PA  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

1/26/2015  Rockville, MD  Save This Job

Director of Regulatory Affairs and Quality Assurance

ABT Molecular

Job Description The Director of Regulatory Affairs and Quality Assurance (Director of RA/QA) is the ABT functional expert responsible for drug regulatory and device quality assurance thereby controlling the efforts and process of ABT ensuring control, efficiency, documentation,

2/11/2015  Louisville, TN  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

1/13/2015  Marlborough, MA  Save This Job

Sr. Manager, Quality Assurance Auditor

Ambit Biosciences

Department: Regulatory Affairs Job Title: Sr. Manager, Quality Assurance Auditor Job Location: San Diego, CA Description: The Q.A. Auditor will work with the Quality Assurance team to develop and fulfill an efficient and effective plan to maximize the value of Ambit?s

2/2/2015  San Diego, CA  Save This Job

Supplier Quality 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 Supplier Quality Manager. SCOPE: The Supplier

1/28/2015  Durham, NC  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

1/27/2015  Meriden, CT  Save This Job

Manager, Logistics

OncoMed Pharmaceuticals

Description: Job Summary The Logistics Manager at OncoMed will be responsible for all aspects of clinical trial materials related to shipping, clinical labeling and packaging and distribution. This includes management of Contract Manufacturing Organizations (CMOs) and internal

1/3/2015  Redwood City, CA  Save This Job

Manager, Clinical Research

Prolacta Bioscience

Department(s): Clinical and Regulatory Affairs Reports to: Chief Scientific Officer Company Prolacta is the pioneer in human milk-based nutritional products for premature infants in the neonatal intensive care unit (NICU). Prolacta believes that there is no adequate replacement

2/18/2015  City of Industry, 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

1/27/2015  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

1/12/2015  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,

1/24/2015  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

1/11/2015  Luverne, MN  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

1/13/2015  Audubon, PA  Save This Job

Marketing Operations

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

1/12/2015  Cambridge, MA  Save This Job

Sr. Clinical Research Associate

Oxford Immunotec

ID 2014-1242 # of Openings 1 Department Clinical Affairs Posted Date 9/29/2014 Job Location US-MA-Marlborough More information about this job: Overview: In-house professional responsible for supporting the initiation, monitoring, and closing out of clinical study sites

11/17/2014  Marlborough, MA  Save This Job