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Manager, Regulatory Affairs Jobs

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Manager, Regulatory Affairs

Sagent Pharmaceuticals

Location: Schaumburg, IL, USA Manager, Regulatory Affairs Department: Regulatory Affairs Reports To: Sr Manager, Regulatory Affairs AND/OR Associate Director Regulatory Affairs Job Summary / Overview: The role is primarily responsible for the management and support of Pre

3/17/2015  Schaumburg, IL  Save This Job

Senior Manager, Regulatory Affairs

Relypsa

Company Overview Relypsa, Inc. is a late clinical-stage pharmaceutical company leading the discovery and development of novel non-absorbed polymeric drugs for important applications in cardiovascular and renal diseases. Relypsa's lead product candidate is patiromer, a

3/21/2015  Redwood City, CA  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

3/15/2015  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

2/21/2015  Cambridge, MA  Save This Job

Regulatory Affairs Associate-Regulatory Operations

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

3/23/2015  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

2/18/2015  Audubon, PA  Save This Job

Manager of Regulatory Affairs and Market Development

FirstFuel Software

Stage 3: Beta Test / Clinical Trials 

ID 2015-1042 # of Openings 1 Location FirstFuel Posted Date 4/7/2015 Category Sales More information about this job: Overview: FirstFuel is seeking a Manager of Regulatory Affairs and Market Development to expand its coverage, understanding, and influence within utility

4/14/2015  Lexington, 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

3/3/2015  Rockville, MD  Save This Job

Manager, Regulatory Operations and Documentation

Inotek Pharmaceuticals

Position Summary Reporting to the Chief Scientific Officer, this person is responsible for planning, managing, and completing with the Project Team, all regulatory projects consistent with company goals. The successful candidate will be accountable for timely planning,

3/25/2015  Lexington, MA  Save This Job

Policy Manager

FiscalNote

Stage 4: Shipping Product $< 5M raised

About Policy at FiscalNote The Policy team functions as the ultimate internal consultant and informs every FiscalNote function: product design, business development, and marketing, to name a few. Leveraging expertise in legislation, regulation, and case law, members of the Policy

3/23/2015  Washington, DC  Save This Job

QA-100. Manager/Senior Manager, Quality Assurance

Quanterix

Job Title: Manager/Senior Manager, Quality Assurance Job Description: Quanterix is an exciting early stage company whose mission is to commercialize a game-changing instrument platform with a menu of immunoassay products that combines proprietary single-molecule sensitivity,

3/20/2015  Lexington, MA  Save This Job

Senior Project Manager (CMC Experience)

Relypsa

Company Overview Relypsa, Inc. is a late clinical-stage pharmaceutical company leading the discovery and development of novel non-absorbed polymeric drugs for important applications in cardiovascular and renal diseases. Relypsa's lead product candidate is patiromer, a

4/20/2015  Redwood City, CA  Save This Job

Clinical Trial Manager

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-?

4/6/2015  Cambridge, MA  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

3/7/2015  Meriden, CT  Save This Job

Quality Assurance Manager

Aegerion Pharmaceuticals, Inc.

Position Description The QA Manager is responsible for quality oversight of contract manufacturing (CMO), packaging and testing activities. Act as primary quality contact/liaison with CMO quality organizations. Serves as product quality representative on cross functional project

3/23/2015  Cambridge, MA  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

2/23/2015  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

3/7/2015  Cambridge, MA  Save This Job

Product Marketing Manager

MedVenture Technology Corporation

Must have Medical Device Industry Experience; Location: Jeffersonville, IN; Minneapolis, MN or Baldwin Park, CA Your tasks Identifies and implements product strategies, marketing plans and promotional programs. Provides key marketing linkage between US and OUS initiatives;

4/6/2015  Jeffersonville, IN  Save This Job

Senior Manager - Medical Information

Relypsa

Company Overview Relypsa, Inc. is a late clinical-stage pharmaceutical company leading the discovery and development of novel non-absorbed polymeric drugs for important applications in cardiovascular and renal diseases. Relypsa's lead product candidate is patiromer, a

3/21/2015  Redwood City, CA  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

2/16/2015  Cleveland, OH  Save This Job