- Takeda Pharmaceuticals (Trenton, NJ)
- …is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as a US Lead , Global Regulatory Policy and Innovation where you ... serve as US expert and subject matter lead for regulatory policy and advocacy activities,...Policy Innovation, you will report to Executive Director & US Head, Global Regulatory Policy… more
- Novo Nordisk (Plainsboro, NJ)
- … regulatory expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute ... human health starts here and that patients rely on us . We're changing lives for a living. Are you...Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead . Essential… more
- Sanofi Group (Bridgewater, NJ)
- **Job title: Global Regulatory Lead ** +...Life Science, or related field) is preferred. **Why choose us ?** + Bring the miracles of science to life ... possible. Ready to get started? **Main responsibilities:** + As Global Regulatory Affairs Lead (GRL),...14 weeks' gender-neutral parental leave. Sanofi Inc. and its US affiliates are Equal Opportunity and Affirmative Action employers… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams ... shine? Join us as an Associate Director, Global Regulatory Project Management and Strategic Planning...**How you will contribute:** + Partnering with the program Global Regulatory Lead (GRL), co-… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …is responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US , EU, Japan, China, and other ... interacts with other therapeutic area leaders and joint Alliance partners. **Responsibilities:** + Lead a multidisciplinary Global Regulatory Team (GRT) to… more
- J&J Family of Companies (Titusville, NJ)
- …plan, risk and opportunity playbooks, scenario evaluation and business case development). + Lead operations with Global Regulatory Team (GRT), including ... projects forward through the translation and distillation of overall global regulatory strategy to executable plans and...in this posting applies to candidates hired in the United States . Candidates hired outside the … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and ... reliability, consistency and efficiency. **Responsibilities** + Plan, coordinate, and review US regulatory submissions in collaboration with USRL, Regulatory… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... therapies to patients worldwide. Join Takeda as Associate Director, Global Labeling Lead where you will be...Represents Global Labeling at Global Regulatory Team (GRT) + Liaises with US … more
- Sanofi Group (Bridgewater, NJ)
- …of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist (RS) leverages their ... strategy, to enable and drive the execution of aligned US , EU and/or global regulatory ...management of products. + May serve as a regional/local regulatory lead and point of contact with… more
- Copeland (Trenton, NJ)
- **About Us ** We are a global climate...will be responsible for processing region payroll in the United States and Canada using ADP GlobalView ... the marketplace knowledge, skills, and competencies to compete and lead in a global economy. Our training...those who are legally authorized to work in the United States . This is not a position… more
- J&J Family of Companies (Titusville, NJ)
- Director, Global Regulatory Leader (GRL) - 2406184564W...payor demands) + Lead the preparation of regulatory dossiers for submissions to US FDA. ... & Johnson Innovative Medicine is recruiting for a Director, Global Regulatory Affairs Leader located in New...more at www.janssen.com . Key Responsibilities: + Bring innovative regulatory approaches, deeply rooted in science, to lead… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …disorders. Summary This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational ... leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This position may...issues. Based on timelines or resources, may assist another Global Labeling Lead by managing labeling development… more
- J&J Family of Companies (Raritan, NJ)
- … Affairs Program Lead will help Robotics & Digital Solutions reach US and international regulatory (NPD) approval goals. Under minimal supervision, the ... Senior Regulatory Affairs Program Lead (Robotics &...new product clearances and approvals. * Prepares and submits regulatory information required to obtain global market… more
- Merck (Trenton, NJ)
- … CMC Oversight + Lead the preparation and submission of high-quality regulatory CMC device content for global submissions, including IND, NDA, BLA, and ... regulatory guidelines and trends. + Collaborate with global regulatory teams to align strategies and...in certain states and cities within the United States . Final determinations with respect to… more
- Merck (Trenton, NJ)
- …are not limited to:_** + Lead a cross-functional team to standardize global medical device requirements including US , EU, UK, Switzerland, Canada, Japan, ... position will be part of the Device Quality & Regulatory Team within Global Regulatory ...in certain states and cities within the United States . Final determinations with respect to… more
- Bristol Myers Squibb (Princeton, NJ)
- …to:** + New Product Portfolio working closely with their TA counterparts in Global Regulatory Strategy, Worldwide Patient Safety (WWPS), Clinical Development and ... **Working with Us ** Challenging. Meaningful. Life-changing. Those aren't words that...global compliant labels. Position will also serve as Global Labeling Lead for assigned products. **Responsibilities… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ... growth, thereby accomplishing corporate goals. **Responsibilities:** + Develop and implement US regulatory strategy for assigned project(s). Strategize and plan… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …the study team, programming lead and management + Support global regulatory authority submissions including preparing programming deliverable for submission ... The Principal Statistical Programmer will lead and support all programming activities per the...support ongoing clinical studies and requests for study report, regulatory submission, and ad hoc/post hoc analysis. The incumbent… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ... growth, thereby accomplishing corporate goals. **Responsibilities** + Develop and implement US regulatory strategy for assigned project(s). + Strategize and… more
- Bristol Myers Squibb (Princeton, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with- us . **Position: VP, Global Program Lead - Hematology Development** ** Global Program ... Lead Role Summary:** The VP - Global Program Leader (GPL) in Hematology Development serves as...+ Working knowledge of regulations in the pharmaceutical industry ( US and Global preferred) + Demonstrated ability… more