Regulatory Affairs Jobs in Gaithersburg
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Search Results - Regulatory Affairs Jobs in Gaithersburg
Green Key Resources-Gaithersburg-
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...
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Green Key Resources-Gaithersburg-
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...
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AstraZeneca-Gaithersburg-
AstraZeneca in discussions with global health authorities and external stakeholders
Key requirements
• Bachelor's degree in Life Sciences, Pharmacy, Biomedical Sciences or related field
• Significant regulatory affairs, regulatory strategy, or drug...
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AstraZeneca plc-Gaithersburg-appcast.io-
for this priority asset. Reflecting the asset’s earlier stage of development, the role will provide proactive commercial and strategic input to development priorities and decisions, working closely with Clinical Development, Global Medical Affairs, Regulatory...
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Green Key Resources-Gaithersburg-
Support GLP and GMP compliance, including on-site inspections
Key requirements
• Bachelor of Science in Chemistry, Biotechnology, or related field; advanced degree preferred
• Minimum 7 years of regulatory affairs experience; 8+ years preferred
• Proven...
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Clinical Dynamix-Germantown (MD), 4 mi from Gaithersburg-
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...
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REGENXBIO-Rockville (MD), 5 mi from Gaithersburg-
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...
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The U.S. Pharmacopeial Convention (USP)-Rockville (MD), 5 mi from Gaithersburg-appcast.io-
engaged, collaborative, and results-driven work environments.
The Senior Advisor – Policy & Regulatory Affairs (LATAM) has the following responsibilities:
Mexico Near-Shoring and USMCA
1. Develop a landscape analysis of the opportunities and barriers...
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REGENXBIO-Silver Spring (MD), 14 mi from Gaithersburg-
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...
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Precigen, Inc-Germantown (MD), 4 mi from Gaithersburg-
Job Description
Job Description
The Senior Manager, Global Promotional Regulatory Affairs is responsible for providing regulatory leadership and guidance for promotional, medical, and other external communications while supporting the development...
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