- 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
- 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
- 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
- WSP USA (Lawrenceville, NJ)
- …standards and timely reporting. + Track and document how local compensation practices and regulatory changes affect global programs and vice versa. ** Global ... organization. + Strong understanding of compensation principles, market practices, and regulatory environments across key global regions. + Exceptional… more
- Balchem (Montvale, NJ)
- Senior Analyst, Global Trade Compliance Department: Legal/ Regulatory Location: Montvale, NJ Start Your Application ... who are engaged in diverse activities, committed to developing the company into global market leadership positions. To learn more about our dynamic, stable and… more
- Bristol Myers Squibb (Summit, NJ)
- …Proven ability to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements **Knowledge & Skills:** + ... Engineers primarily work with local (site) Business Process Owners, Global MS&T, Global IT, Cell Therapy Network subject matter experts, MSEO Operations… more