- Merck (Rahway, NJ)
- …large molecule programs across a variety of platforms + Expert knowledge in global regulatory requirements for large molecule commercialization and BLA assembly ... working teams supporting the product. + Compile with our company's Global and regulatory requirements and execute current Good manufacturing Practices (cGMP) in… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …including but not limited to Translational Research & Biomarkers, Clinical Management, Global Regulatory Affairs, Global Clinical Development (late phase), ... endpoints ensuring seamless integration across discovery, nonclinical, clinical pharmacology, regulatory , and commercial functions. As an industry-leading expert and… more
- Sanofi Group (Morristown, NJ)
- …problem scoping and planning. + Good knowledge of industry best practices, global regulatory , processes, standards of drug development. **Demonstrate the ... potential drug-drug interactions, quantifying benefit-risk relationships, and contributing to regulatory submissions and interactions from first-in-human studies through life-cycle… more
- Sanofi Group (Morristown, NJ)
- …larger teams. + Significant regulatory experience, with preference for experience with global regulatory submissions. + This position may require up to 25% ... could be critical in helping our teams accelerate progress. We are an innovative global healthcare company with one purpose: to chase the miracles of science to… more
- J&J Family of Companies (Titusville, NJ)
- …Global Development Ontology to enable semantic consistency across operational and regulatory domains. + Align Global Development Ontology with enterprise ... enterprise ontologies, knowledge graphs, and catalogs. + Collaborate with Global Development stakeholders-including Clinical, Regulatory , Medical Writing, QA,… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …of commercial manufacturing. + Extensive knowledge of FDA/EMEA cGMPs and other global regulatory compliance guidelines (eg, ICH) for drug manufacturing, ... Statistician / Principal Statistician is a core team member of the global statistics group, responsible for providing statistical support for drug substances, APIs,… more
- 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
- Bristol Myers Squibb (Summit, NJ)
- …+ Proven ability to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements. + Support health authority and ... used in the production of personalized cell therapy products for both global clinical trials and commercial supply. The incumbent must be self-directed,… 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
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