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Sanofi
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Meriden, CT
Preferred Qualifications: Degree in a scientific field (Biology or Life Sciences) Demonstrated knowledge in microbiology, immunology, virology, or bacteriology....
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2 days ago
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Sanofi
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Meriden, CT
Preferred Qualifications: Degree in a scientific field (Biology or Life Sciences) Demonstrated knowledge in microbiology, immunology, virology, or bacteriology....
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2 days ago
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Intercept Pharmaceuticals, Inc.
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San Diego, CA
Solid understanding of/experience in global CTA submissions Solid understanding of the cross functional drug development processes (Clinical Operations, Data Management, Biostats, and Regulatory) REQUIRED...
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3 days ago
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IQVIA
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Durham, NC
ISO 31000) Strong knowledge of the ICH Guidelines, FDA regulations, the EU Clinical Trial Regulation, EU Directives, MHRA Statutory Instruments, EMA PV requirements and other relevant laws, regulations...
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15 hours ago
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Biomarin
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San Rafael, CA
trials including protocols, investigator brochures and investigator information Annual Reports Representing the Regulatory Affairs function on assigned cross-functional project teams and to external...
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3 days ago
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Ascent Services Group
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Oakland, CA
Review Board (IRB) and central IRBs for review regulatory activities associated with clinical trials and compassionate uses for the Northern California region....
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2 days ago
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Cypress HCM
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San Rafael, CA
trials including protocols, investigator brochures and investigator information Annual Reports Representing the Regulatory Affairs function on assigned cross-functional project teams and to external...
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2 days ago
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PCI Synthesis
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Newburyport, MA
DIRECTOR OF QUALITY ASSURANCE This position, a member of the senior management team reporting to the COO, requires a well-organized, results-oriented individual who will focus on all of the...
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4 hours ago
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Pfizer Inc.
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Creamery, PA
development or manufacturing lifecycle and works to support the Upjohn product portfolio....
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3 days ago
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Teva Pharmaceutical Industries
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Parsippany, NJ
Demonstrates a basic understanding of pharmaceutical drug development for respiratory products. Ability to manage timelines within a project team environment....
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2 days ago
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BioPhase Solutions
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San Diego, CA
Regulatory Affairs Manager We are looking for a Regulatory Affairs Manager to join the the team at a great local Biotech to manage the accumulation of technical information and prepare submissions...
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1 day ago
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Stoke Therapeutics, Inc.
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Cambridge, MA
ICH GCP) Independent self-starter is a must Travel: Approximately 10-20% of this position will require travel....
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1 day ago
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Arena Pharmaceuticals
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San Diego, CA
Experience providing guidance during submission planning by applying knowledge of FDA, Canadian, EU and ICH guidelines related to clinical trial and marketing applications....
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1 day ago
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Simply Biotech
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San Diego, CA
CLIA Director of Quality Assurance - Simply Biotech OVERVIEW Are you looking for a new career opportunity with an exciting biotech company?! Then weve got the right team for you! In this role,...
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2 days ago
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Merck & Co., Inc.
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North Wales, PA
Support for Clinical Trial Applications (CTA's) in Phase I-III as well as Marketing Authorization filings, and post filing activities....
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3 days ago
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The...
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