Drug Regulatory Affairs Jobs in Burlington, MA

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Executive Director, Medical Writing  

MapLight Therapeutics, Inc. - Burlington, MA, United States

, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms. What You’ll Do: Reporting to the VP, Regulatory Affairs

from: linkedin.com - 17 days ago

Director, Non-Clinical Toxicology  

MapLight Therapeutics, Inc. - Burlington, MA, United States

Collaborate with CMC, Program & Portfolio Management, Clinical, and Regulatory Affairs to develop program-specific strategies for appropriate data generation in support of development candidate nomination, IND

from: linkedin.com - 20 days ago

Head of Statistical Programming – US  

Sobi - Waltham, Massachusetts

Program Leader Clinical Study Manager Medical Director Lead Medical Program Lead Drug Safety Manager and Physician Regulatory Affairs Manager Clinical Pharmacologist Marketing IT QA Patient Access External

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from: resume-library.com - 3 days ago

Director- Commercial Distribution and Trade Affairs  

Apnimed - Cambridge, MA, United States

launch First product launch with a company a plus Experience in a small company is a plus Experience and understanding with relevant regulatory and legal policies such as the Drug Supply Chain Security Act

from: linkedin.com - 4 days ago

Regulatory Manager  

BostonGene - Waltham, MA, United States

. Provide regulatory support for due diligence activities related to external diagnostic companies. Qualifications PhD and/or MS degree preferred within Regulatory Affairs, Life Sciences, or Engineering. 6

from: linkedin.com - 6 days ago

Consumer Safety Officer  

Food and Drug Administration - Stoneham, Massachusetts (+2 locations)

Services (DHHS), Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Office of Medical Products and Tobacco Operations (OMPTO), Office of Biological Products Operations (OBPO), which

from: Usajobs.gov - 10 days ago

VP, Early Clinical Development  

Astria Therapeutics, Inc. - Boston, MA, United States

Development, Clinical Operations, Regulatory Affairs, Nonclinical Development, Pharmaceutical Sciences, Discovery and Translational Sciences and other functions in driving asset and company strategy to fruition

from: linkedin.com - 6 days ago

CSV/ Validation Engineer  

Beacon Hill Staffing Group - Waltham, MA, United States

, Pharmacovigilance/Drug Safety, Medical Affairs, Supply Chain, Regulatory Affairs and Quality Assurance is a plus Experience with ValGenesis is a plus Practical experience with quality risk management and risk-based

from: linkedin.com - 14 days ago

Vice President, Oncology Breast Therapeutic Area Medical Head , NMD at Pfizer  

Pfizer - Cambridge, Massachusetts

potential of our existing and future commercially available medicines. + The role will partner closely with Pfizer Oncology stakeholder groups (including Research, Early and Late Development, Regulatory

from: HealtheCareers.com - 14 days ago

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Senior Director/Director, Global Regulatory Affairs Lead  

Corbus Pharmaceuticals - Norwood, MA, United States

in Regulatory Affairs Experience in all types of regulatory submissions including but not limited to INDs, NDAs, MAA, Type A-D Meetings with FDA, Scientific Advice Consultations with the CHMP of EMA and MHRA, MAA

from: linkedin.com - 4 days ago


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