- Danaher Corporation (Denver, CO)
- …of Global Quality and Regulatory Affairs . The Director of Global Regulatory Affairs will be responsible for developing and executing ... human health. This position is part of Quality and Regulatory Affairs located in Fargo, ND and...ensuring accuracy, completeness, and timeliness. + Monitor and interpret global regulatory requirements and trends, provide strategic… more
- Takeda Pharmaceuticals (Denver, CO)
- …of technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at internally ... for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices… more
- Fresenius Medical Center (Aurora, CO)
- …AND SCOPE:** Assists in the support of the daily operational activities within Regulatory Affairs for the preparation of regulatory submissions required ... RESPONSIBILITIES:** + A seasoned, experienced professional with a full understanding of Regulatory Affairs ; resolves a wide range of issues in creative ways. +… more
- Sumitomo Pharma (Denver, CO)
- …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 ...pharmaceutical industry with minimum of 8 years focused in regulatory affairs . + Master's degree required (preferably… more
- Takeda Pharmaceuticals (Denver, CO)
- …working groups to liaise effectively with cross-functional team members (Program Management, Global Regulatory Affairs , Regulatory Operations, Drug ... on cross-functional teams (Clinical, Global Patient Safety, Program Management, Global Regulatory Affairs , Regulatory Operations) to plan, generate,… more
- Takeda Pharmaceuticals (Denver, CO)
- …with US and EU standards and guidelines. Serve as the expert for device labeling on the global Regulatory Affairs (RA) Sub team and Global Device Sub ... life-changing therapies to patients worldwide. Join Takeda as the Senior Manager, Global Labeling Devices. You will...issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk… more
- Takeda Pharmaceuticals (Denver, CO)
- …with Senior Management Cross-Functional Team (GLOC)** + In alignment with Head, Global Regulatory Affairs Marketed Products and Labeling, coordinates the ... process to obtain labeling approval by Labeling Senior Management Cross-functional team ( Global Labeling Oversight...issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk… more
- Sumitomo Pharma (Denver, CO)
- …internal company programs and external facing HCP and Payer interactions. The Sr . Director of Medical Affairs develops and maintains professional relationships ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the US (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma… more
- Sumitomo Pharma (Denver, CO)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Senior Manager, Medical Affairs Technology and Digital Innovation** . **Job ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...the development, implementation, execution, and oversight of Medical Information/Medical Affairs digital services and innovative digital projects as well… more
- Sumitomo Pharma (Denver, CO)
- …approach to planning, executing, and problem solving + Working knowledge of current global regulatory requirements and guidelines for clinical trials. The base ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key...highly motivated, and experienced individual for the position of ** Senior Clinical Project Manager, Medical Affair.** The Senior… more
- Merck (Denver, CO)
- …scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations) ... Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs , and late-stage Clinical Research throughout… more
- Edwards Lifesciences (Denver, CO)
- *We will consider candidates who qualify for either the ** Senior Principal Biostatistician** (Individual Contributor/ Subject Matter Expert) or the ** Senior ... and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to… more
- Sumitomo Pharma (Denver, CO)
- …and final study reporting. + Collaborate with cross-functional teams, including clinical, regulatory , and medical affairs , to ensure study designs meet ... + Interpret and communicate statistical findings to non-statistical audiences, including senior leadership, regulatory agencies, and external stakeholders. +… more
- Takeda Pharmaceuticals (Denver, CO)
- …+ Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned ... coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team ( Global Labeling Oversight...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more
- Takeda Pharmaceuticals (Denver, CO)
- …communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs , Quality Assurance, Medical Affairs , Marketing, ... knowledge. **Job Description** **Objective:** **Principal responsibilities include:** + Serves as Global Safety Lead (GSL) and the Company-wide patient safety expert… more
- S&P Global (Englewood, CO)
- …senior Risk & Compliance management as necessary. + Consult with the Legal & Regulatory Affairs Department, as needed, to resolve complex regulatory and ... Organization to provide advice and guidance related to risk, regulatory and compliance. The role will be a point...You Stand To Gain:** The position requires interaction with senior stakeholders in S&P Global Ratings (including… more
- Cardinal Health (Denver, CO)
- …collaborate with cross functional partners including but not limited to Global Product Management, Digital Marketing, Finance, Capital Service, Medical Affairs ... Clinical Operations Supply Chain and Operations, Research & Development, Strategic Pricing, Regulatory and Legal + Develop business proposals for national and local… more