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FDA Pharmacovigilance Auditor
SQA Services
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New York City, NY
... What you’ll need: You will need to have expertise in US FDA Pharmacovigilance regulations. You will need experience managing PV agreements with multiple parties and assertiveness dealing with difficult auditees. As an SQA Quality Auditor, you will ... - May 22
Quality Assurance Engineer
10XBeta Venture Studio
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Manhattan, NY, 10261
... Preferred: ● Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 60601-1, IEC 62304, FDA’s General Principles of Software Validation. ● Passion for the development and execution of new technologies, including the ability to apply and manage ... - May 17
Senior Director, Commercial Regulatory Affairs
Mitsubishi Chemical Group
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Jersey City, NJ
... Develops FDA/OPDP and Health Canada strategy and execution of related communications as part of thePromotional Materials Review Committee (PMRC), a cross-functional team of representatives from various business areas (Marketing, Market Access, Sales ... - May 16
Quality Assurance Engineer
10XBeta Venture Studio
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Manhattan, NY, 10261
... Preferred: Working knowledge of ISO 13485, ISO 14971, 21 CFR 820, IEC 60601-1, IEC 62304, FDA's General Principles of Software Validation. Passion for the development and execution of new technologies, including the ability to apply and manage ... - May 16
Senior Director, Clinical Operations
Mitsubishi Chemical Group
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Jersey City, NJ
... As a senior member of Clinical Operations, the Senior Director, Clinical Operations will lead the full development team in designing, planning, implementing, and executing clinical trials and programs in accordance with company SOPs, and FDA/ICH ... - May 16
HCG - MES Engineer
Horizon Controls Group
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Manhattan, NY, 10001
... Compliance and Regulatory Support: Stay up to date with relevant regulatory guidelines and industry standards (e.g., FDA, GMP) pertaining to MES systems. Assist in ensuring compliance with these regulations through proper system configuration, data ... - May 02
Senior Medical Director - Medical Science (US Remote)
Mitsubishi Chemical Group
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Jersey City, NJ
... Medical Science will lead the early- to late-stage development team(s) in designing, planning, implementing and executing clinical development plans and programs in accordance with company processes, SOPs, and FDA/ICH guidelines and regulations. ... - May 16
Associate Director, Medical Affairs - Parkinson's
Mitsubishi Chemical Group
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Jersey City, NJ
... Thorough understanding of the FDA, HIPAA, and other ethical and legal guidelines relevant to the pharmaceutical industry. Must be able to travel ~20% due to conferences and meetings. Excellent communication (oral and written) and presentation skills ... - May 16
Sr. Director of Engineering
DSJ Global
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Manhattan, NY, 10261
... Familiarity with relevant quality and regulatory requirements and trends and cGMP’s (e.g., FDA, EU Annex 1, PIC/S, PDA, ISPE, Pfizer PQS, etc.). In depth knowledge of one or more of the following areas: Fill/Finish equipment & aseptic processing ... - Apr 26
Customs Specialist
Alchemy Global Talent Solutions
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New York, NY
... Customs entries for Imports Filing ADD/CVD, FDA, EPA, TSCA, and OGA data Ensure that all documents required by U.S. Customs are correct and in compliance with U.S. Customs regulation. Completing Import shipments Develop and maintain customer ... - May 19