| Job alert | Jobs 11 - 20 of 860 |
Executive Director Regulatory Affairs Team Leader
CLevelCrossing
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Jersey City, NJ
... and/or approve key documents before major regulatory submissions (US and/or global) Maintain oversight of key interactions with FDA Communicate FDA feedback as appropriate to regulatory management team Act as a strategic partner in the governance ... - Jun 10
Data Acquisition Lead (FSP)
Intone Networks
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Manhattan, NY, 10019
... Technical/Functional Expertise - Working knowledge and understanding of FDA and ICH regulations and industry standards and quality control principles. - Experience with all phases of drug development. - Solid Experience in handling Clinical data ... - Jun 16
Clinical Safety Reviewer
Cardiovascular Research Foundation
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Manhattan, NY, 10261
... Demonstrates knowledge of safety concepts, per ICH and FDA guidelines per device/drug safety reporting requirements. Identifies proper case regulatory reporting requirement and seeks assistance when necessary. Identifies and utilizes resources and ... - Jun 09
Manager, Clinical Supply Chain
TG Therapeutics, Inc.
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Manhattan, NY, 10261
... In addition to a research pipeline including several investigational medicines, TG has received approval from the United States Food and Drug Administration (FDA) for BRIUMVI (ublituximab-xiiy) for the treatment of adult patients with relapsing ... - Jun 18
Life Science Equity Partner
Interlink Talent Solutions
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New York, NY
... Collaborate with interdisciplinary teams to address diverse legal needs, including clinical trial agreements, intellectual property protection, regulatory compliance, pricing and coding strategies, FDA interactions, and fraud and abuse mitigation. ... - May 25
Director of Quality
Barrington James
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Manhattan, NY, 10037
... This pivotal role involves leading the Quality Management program ensuring compliance with FDA regulations & supporting new product launches. Job Responsibilities: You will be responsible for ensuring compliance with FDA cGMP and cGTP regulations. ... - Jun 18
Technology Transactions Life Sciences Associate
Vanguard-IP
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Manhattan, NY, 10261
... law firm experience representing biotechs and big pharmas as they license patents and collaborate to advance novel therapeutics, vaccines, diagnostic and digital health technologies through clinical trials and toward regulatory (FDA) approval. ... - Jun 13
QA Coordinator, Cell Therapy & Engineering
Memorial Sloan Kettering Cancer Center
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Manhattan, NY, 10017
... Regulatory Compliance: Prepare and respond to FDA inquiries, ensuring compliance and timely communication. Product Test Record Review: Review product test records for completeness and accuracy. Quality Concerns Management: Raise quality concerns ... - Jun 15
Field Service Engineer
Rezolut
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Manhattan, NY, 10038
... Adhering to current regulatory requirements to include, but not limited to, HIPPA, OSHA and FDA. Establish and maintain proper business relationships with customers and peers as well as performing necessary administrative duties as required and ... - Jun 04
Director GMP Process Development
nyscf
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Manhattan, NY, 10261
... Knowledge of FDA and EU cGMP regulations and requirements as they relate to process and assay development. Experience in developing assays for transfer into a GMP testing lab. Understanding of cell culture processes, such as: scale up factors from ... - Jun 07