- Oracle (Trenton, NJ)
- …renewal. + Ensure all hardware and processes adhere to company and global regulatory requirements; maintain audit readiness through documentation and system ... **Job Description** Oracle's Global Physical Security (GPS) Systems Team is committed...delivering secure and seamless access credentialing across the corporation's global offices and data centers. We are seeking an… more
- Sanofi Group (Morristown, NJ)
- …project under the leadership of the Global Project Head, with the Global safety Officer, Regulatory Strategist and other key functional representatives to ... deliver development strategy and prepare/assist with regulatory bodies interaction + Provide clinical scientific expertise in the Study team to conduct the clinical… more
- Deloitte (Morristown, NJ)
- …support. + Regulatory Compliance: Ensure all solutions and processes meet global regulatory requirements (eg, FDA, EMA, PMDA) and industry best practices. ... You will lead and deliver complex projects that drive innovation, regulatory compliance, and operational excellence for pharmaceutical, biotech, and medical device… more
- Regeneron Pharmaceuticals (Warren, NJ)
- …reports or support programmers on assignment status + Lead and support global regulatory authority submissions including preparing programming deliverable for ... providers for all programming deliverables from the single study through to regulatory approval, product launch, data monitoring boards, regulatory safety… more
- Merck (Rahway, NJ)
- …risk, generate gap analysis and mitigation strategies + In-depth knowledge of global regulatory requirements for medical devices and combination products and ... skills to shape the technical capabilities and strategic direction for a global , cross-modality technical team. As an individual contributor, the associate director… more
- Merck (Rahway, NJ)
- …risk, generate gap analysis and mitigation strategies + In-depth knowledge of global regulatory requirements for medical devices and combination products and ... leadership skills to shape the technical capabilities and strategic direction for a global , cross-modality technical team. The Director will lead a team of technical… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …ensuring self and project teams are acting in compliance with GMP and US and global regulatory requirements (FDA, ICH, EMEA, and WHO) and industry standards. + ... and external functional representatives (CMOs, Manufacturing, Supply Chain, Quality Assurance, Regulatory , etc.) to deliver products that are commercially viable and… more
- Oracle (Trenton, NJ)
- …Staff to play a critical technical leadership role to ensure FDA and global regulatory compliance, including secure design, architecture and software development ... and ensure product is maintaining compliance to FDA and other Global regulatory requirements. - Proficiency in the Java programming language. Python programming… more
- Merck (Rahway, NJ)
- …generate gap analysis and mitigation strategies + In-depth knowledge of global regulatory requirements for distribution including good distribution practices. ... the Director Packaging Distribution, Components and Systems COE, the Director, Global Distribution Engineering and Technology, will be responsible and accountable… more
- ThermoFisher Scientific (Lawrenceville, NJ)
- …of GLP-compliant bioanalytical workflows and method development. * In-depth knowledge of global regulatory expectations (FDA, ICH, EMA) for PK and immunogenicity ... Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our… more