Regulatory Affairs Jobs in Maryland
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Search Results - Regulatory Affairs Jobs in Maryland
Disability SolutionsRockville (MD)
benefits and life at GSK on our webpage Life at GSK | GSK
Find out more about GSK and R&D: Our approach to R&D
Global Regulatory Affairs Manager, Oncology
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion...
REGENXBIOSilver Spring (MD)
programs
• Collaborate across R&D, Quality, Manufacturing, Supply Chain, Medical Affairs, Pharmacovigilance, and Regulatory Affairs to deliver dossiers
• Coordinate with EU, Japan, and other markets to shape ex-US strategies and engage with local agencies...
1 similar job: Rockville
Clinical DynamixGermantown (MD)
Position Summary
Our Startup Client is seeking an experienced Vice President of Quality & Regulatory Affairs to lead the Quality and Regulatory functions for a clinical-stage biotechnology company developing innovative cell-based therapies...
Fort Detrickgoldbelt.com
Affairs Support – WEMT.
Responsibilities:
Essential Job Functions:
• Develop and review regulatory strategies for drugs, biologics, blood products, and medical devices.
• Prepare/review INDs, NDAs, PMAs, 510(k)s, technical files and clinical evaluation...
Green Key ResourcesSilver Spring (MD)
regulatory experience
• Extensive experience in CMC regulatory affairs, including eCTD authoring and submission management
• Knowledge of FDA, EMA, and Health Canada requirements for various dosage forms
• Experience in manufacturing, QA/QC, and product...
1 similar job: Gaithersburg
Placement Services USA, Inc.Rockville (MD)jobvertise.com
Requirements
Bachelors degree in Pharmaceutical Sciences or related.
Special Skills Requirements
Two (2) years of experience evaluating European Union Regulatory compliance, analyzing regulatory trends, and managing regulatory affairs projects.
Partial...
InsmedBaltimore
correspondence and submissions accurately; ensure lifecycle management activities
Key requirements
• Bachelor’s degree in a scientific discipline
• 10+ years in Global CMC Regulatory Affairs or relevant pharma/biotech development experience
• 5+ years of gene...
Green Key ResourcesGaithersburg
Regulatory Affairs Manager / Senior Manager
Gaithersburg, MD | Hybrid, onsite Tuesday through Thursday
Green Key Resources is recruiting for a highly technical, 100% hands on CMC regulatory role focused on commercial stage pharmaceutical products...
Structure TherapeuticsBaltimore
Regulatory Affairs, Biostatistics, and cross-functional teams to ensure submissions meet high-quality and regulatory standards. You will drive document management best practices and provide cross-functional leadership in a remote-first environment.
This role...
KellyBethesda (MD)
research protocols.
• Educate and counsel patients participating in clinical trials.
• Expert in regulatory affairs related to clinical trials research
• Facilitate the lifecycle of clinical research trials
• Work closely with a diverse team of health care...
DeloitteBaltimore
Overview
In this role you will lead strategic engagements in global regulatory affairs and policy; shape risk-based recommendations for life sciences and health care clients. You will collaborate with cross-functional teams to translate regulatory...
1 similar job: Mclean
PwCBaltimore
Affairs, or Regulatory Affairs- Supporting R&D activities within contract research organizations (CROs), academic research, regulatory health authorities, or life sciences consulting environments. - Applying knowledge of the R&D lifecycle, industry trends...
UPMC - Pittsburgh Medical CenterCumberland (MD)
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Regulatory Affairs Management: Participates in regulatory compliance activities and maintains continuous departmental readiness for inspections and surveys. Follows all radiation safety standards. Wears radiation monitoring badge and I.D...
Lockheed MartinPatuxent River
federal and/or state legislative and regulatory affairs with elected officials and government officials in regulatory and other agencies and their respective staffs. Responsible for coordinating subordinate employee recruitment, selection and training...
Silver Spring (MD)icims.com
Position Summary:
Odyssey is looking for a Regulatory Affairs SME 2, to support the Defense Health Agency (DHA) at Ft. Detrick, MD. The Regulatory Affairs Subject Matter Expert 2 acts alongside RA SME 1 to provide specialized regulatory guidance...
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