- Merck (Rahway, NJ)
- … Process Owner for one or more of the QMS processes managed under GRACS( Global Regulatory Affairs & Clinical Safety) Quality &Compliance. + Establishes and ... a Subject Matter Expert (SME) for functional group processes, systems, and regulatory knowledge. + Applies capabilities to enhance quality and builds capabilities of… more
- Coinbase (Trenton, NJ)
- …day, as we build the emerging onchain platform - and with it, the future global financial system. To achieve our mission, we're seeking a very specific candidate. We ... you will work in a fast-paced environment supporting a wide variety of regulatory advocacy and the development of new policy positions, including by developing… more
- Ascendis Pharma (Princeton, NJ)
- Ascendis Pharma is a dynamic, fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States. Today, we're advancing programs ... within Medical Writing. Furthermore, you have: + Experience in authoring clinical/ regulatory documents. + Excellent verbal and written communication skills with the… more
- Bristol Myers Squibb (Princeton, NJ)
- …or Madison, New Jersey **Position Summary** The Director of Early Precision Medicine Regulatory Affairs leads global regulatory strategy for biomarkers and ... Drive the development and actively support the execution of innovative, compliant global regulatory strategies that enable cutting-edge biomarkers and diagnostic… more
- Sanofi Group (Morristown, NJ)
- …could be critical in helping our teams accelerate progress. As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global ... their regulatory expertise to contribute to the definition of the global regulatory strategy, to enable and drive the execution of aligned US, EU, and/or… more
- Sumitomo Pharma (Trenton, NJ)
- …groups + Responsible for providing global guidance and monitoring of global regulatory line items in the clinical development projects budget process ... address the interests of the Company + Highly developed understanding of global regulatory dynamics + Unquestionable ethics, professional integrity, and personal… more
- Sumitomo Pharma (Trenton, NJ)
- …position of **Director Regulatory Affairs** . The Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily ... function as the Regional Regulatory Leader (RRL) and/or Global Regulatory Leader (GRL) for assigned projects. This position is expected to lead the… more
- J&J Family of Companies (Raritan, NJ)
- …leader, driving projects forward through the translation and distillation of overall global regulatory strategy to executable plans and the coordination of ... are aligned with compound/program objectives and commitments. Work closely with the Global Regulatory Leader (GRL) and partners across Global Regulatory … more
- Sanofi Group (Morristown, NJ)
- …GSS filing plans for Sanofi R&D's priority growth assets. + Represent GRO on the Global Regulatory Teams for Sanofi GBU priority assets, per the GRA BluePrint ... Accountable for the delivery of high quality and timely submissions to global regulatory health authorities which are aligned to both Sanofi and Health Authority… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …regulatory strategies to collaborators. + Support development and execution of global regulatory strategies by collaborating closely with international ... ensure regulatory compliance. + Prepare, submit, and maintain global regulatory submissions and registrations. + Write and update standard operating… more
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