- Genmab (Plainsboro, NJ)
- …time per our hybrid policy.ResponsibilitiesReporting to the Team Lead of Regulatory Strategy , Global Regulatory Affairs, the key responsibilities include but are ... for an experienced and passionate leader to be a part of our Global Regulatory Affairs (GRA) organization.In this role, the regulatory leader will be primarily… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an ... of AEs, medical history, and medications when needed Clinical Development Expertise Strategy :In collaboration with the Global Clinical Lead (GCL), if applicable,… more
- Merck & Co. (North Wales, PA)
- …regulations, corporate standards and policies and business objectives.Actively participate in labeling and global regulatory team meetings to ensure support ... Job DescriptionReports to the Director/ Senior Director in the Office of Promotion and...for anticipated promotional messages and claims (aligned with marketing strategy ) in clinical trial design and product labeling… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …role will interface with key stakeholders across CMR, Marketing, and the Global organization to drive scientific exchange and communication with external Key Opinion ... (HCPs), and other stakeholders. The Medical Director will also assist the Senior Medical Director in the development and execution of strategic priorities within… more
- Takeda Pharmaceuticals (Columbus, OH)
- …plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases. The Director, Global Labeling Strategy Lead is a key role in ... of the labeling strategy and labeling content. **Interface with Senior Management Cross-Functional...the process to obtain labeling approval by Labeling Senior Management Cross-functional team ( Global… more
- Takeda Pharmaceuticals (Columbus, OH)
- …bring life-changing therapies to patients worldwide. Join Takeda as Senior Manager, Global Regulatory Labeling Strategy where you will be responsible for ... the process to obtain labeling approval by Labeling Senior Management Cross-functional team ( Global...discussions to ensure cross-functional collaboration and alignment of the labeling strategy and labeling content… more
- Amgen (Washington, DC)
- …is to develop and maintain quality core and regional labeling documents and drive global labeling strategy to ensure safe and effective use of Amgen ... and healthcare providers around the world. As part of Global Labeling Strategy and Compliance...Area Obesity and Related Conditions Assistant Vice President, the Labeling Strategist, Sr . Manager is responsible for… more
- Takeda Pharmaceuticals (Columbus, OH)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as the Senior Manager, Global Labeling Devices. You will be responsible for ... cross-functional teams, driving cross-functional collaboration and alignment of the labeling strategy and labeling content...process to obtain IFU labeling approval by Labeling Senior Management Cross-functional team ( Global… more
- Takeda Pharmaceuticals (Columbus, OH)
- …collaboration and alignment of the labeling strategy and labeling content. Interface with Senior Management Cross-Functional Team (GLOC) + In ... the process to obtain labeling approval by Labeling Senior Management Cross-functional team ( Global...- GLOC) driving cross-functional collaboration and alignment of the labeling strategy and labeling content… more
- Takeda Pharmaceuticals (Boston, MA)
- …post-GLOC ( Global Labeling Oversight Committee) endorsement. + Understand the labeling regulatory strategy on the Global Regulatory Team (GRT) to ... CCDS into latest CCDS template, confirms 100% content transfer, and highlights to Global Labeling Lead (GLL) possible areas for functional team review. Ensures… more
- Amazon (Seattle, WA)
- …and transportation solutions. The Supply Chain team is seeking an experienced Sr . Global Commodity Manager for OEM Robotic Technologies (Robotic Arms, ... decisions to support new product introduction and long-term commodity strategy . The ideal candidate for this position will be...without capacity constrain, while achieving cost reduction goals. The Sr . Global Commodity Manager has an important… more
- GRAIL (Menlo Park, CA)
- …North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, ... be responsible for establishing, implementing, maintaining, and improving GRAIL's product labeling program and acts as technical lead supporting technical operation… more
- AbbVie (North Chicago, IL)
- …Job Description The Associate Director, Regulatory Affairs Strategic Global Labeling and Operations, provides leadership, employee management, strategy and ... program management for Regulatory Affairs in the area of labeling using our current systems. Provides leadership in the...queries and reports from regulatory systems and provide to Senior Management and/or to satisfy an audit request. +… more
- Chiesi (Cary, NC)
- Global Regulatory Affairs Labeling & Promotional Manager Date: Jan 23, 2025 Department: Global Regulatory Affairs Job Type: Direct Employee Team: R&D, ... group to be awarded **B Corp Certification** , a recognition of **high social and environmental standards.** We are...in product development and lifecycle management aligned to the global labelling and promotional strategy . + Support… more
- Fujifilm (Holly Springs, NC)
- …commitments with FDBN Analytical Method Capabilities and the FDBN company vision/mission ( strategy and compliance). The Sr . Specialist 2, QC PQM ensures ... **Position Overview** The Sr . Specialist 2, Quality Control Program Manager (QC...will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Boehringer Ingelheim's high regard for our employees. With minimal assistance from senior labeling management: + Marketed products and Late Stage Development ... No international experience required. + Must be able to lead specific strategy /planning activities for labeling implementation. When confronted with more… more
- Amazon (Lockbourne, OH)
- …from scratch, including developing, leading, and driving proactive execution of a global regulatory strategy . They must enjoy problem solving and possess ... Working as part of the Medical Devices Operational Compliance Team (MD-OCC), the Sr . Regulatory Affairs Specialist will be working to build best in class products.… more
- BioFire Diagnostics, LLC. (Salt Lake City, UT)
- The Sr . Regulatory Affairs Manager will work with a high level of autonomy to oversee the regulatory processes of lifecycle and change management while managing the ... This person will lead and contribute to the development of regulatory strategy linked with Change Management and conduct assessments of regulatory changes and/or… more
- Fujifilm (Holly Springs, NC)
- **Position Overview** The Sr Engineer or Scientist of Process Validation 1 ensures that manufacturing processes meet the validation and regulatory requirements to ... it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs,… more
- LinkedIn (Mountain View, CA)
- …careers. Our vision is to create economic opportunity for every member of the global workforce. Every day our members use our products to make connections, discover ... team members are proactive, motivated, organized, and possess a global perspective - and able to work well in...team-oriented environment. The Trust team is looking for a Sr Trust Risk Manager who will play a key… more
