- Oracle (Trenton, NJ)
- …are occurring and changing at an unprecedented rate, the success of large, complex global health companies requires regulatory leaders who are deeply steeped in ... applications to Health Canada, and other global submissions) across global market ensuring compliance with regulatory authorities. + Maintain documentation… more
- Merck (Rahway, NJ)
- …of experience in global patient advocacy and engagement activities + US/ global experience in regulatory affairs, medical and scientific affairs, and ... **Job Description** The Executive Director and Global Lead, Patient Advocacy & Strategic Alliances position...in the Value & Implementation (V&I) organization, which includes Global Medical and Scientific Affairs as well as Outcomes… more
- Indeed (Newark, NJ)
- …KPIs; analyze benchmarking data and present insights to executive leadership. + Ensure global and local regulatory compliance in partnership with Legal and ... a key person responsible for shaping and executing Indeed's global benefits strategy. This is meant to enhance the...through exceptional benefits programs. This is a highly visible, global leadership role. It is ideal for someone who… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …product development and change control, ensuring compliance with US, EU, and other global regulatory requirements. + Author FDA submissions (eg, 510(k), Q-Sub), ... EU technical documentation under MDR, and other global regulatory filings. + Evaluate medical device regulations and lead the development of global … more
- Sanofi Group (Morristown, NJ)
- …families. Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team ... department bridges the gap between technical development, manufacturing operations, and global regulatory authorities to ensure compliance while optimizing… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …programs from initial feasibility through full-scale commercialization. + Partner with global regulatory (clinical and CMC) for developing combination products ... with an advanced degree. Regulatory Expertise: Direct experience with global regulatory submissions and agency interactions for combination products Project… more
- J&J Family of Companies (Raritan, NJ)
- …with JJT-TS, EQ and business Segments to ensure that J&J Quality Standards and global regulatory requirements are met and will drive integration of new or ... **External Advocacy** **(20%)** + Leads the monitoring efforts for external global regulatory environment for new or changing regulatory requirements and… more
- Taiho Oncology (Princeton, NJ)
- …Agreements (PVA's), or other Contracts to ensure GVP compliance. + Liaise with global Regulatory Agencies. + Liaise with TOE and Taiho Pharmaceuticals Co., ... guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are… more
- J&J Family of Companies (Titusville, NJ)
- …clinical study reports and for the preparation and approval of essential documents for global regulatory filings. The CL will manage direct reports who are ... matrix interactions also includes individuals from project management, TA strategy, global regulatory affairs, finance, legal, quality assurance, quality… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …proficiency with Microsoft Word and Adobe Acrobat, and a strong understanding of global regulatory submission standards (ICH, FDA, EMA). A Clinical Publisher in ... Global Regulatory Medical Writing (GRMW) Operations provides basic support to GRMW (and other departments as appropriate) in the production of submission-ready… more