- Sanofi (Waltham, MA)
- …Context of the job/major challenges (S)He interacts with other GBS teams, Clinical, Regulatory , Global Program Head, Regulatory , Immunology, Medical Writing, ... Job Title: Senior Project Biostatistics Lead - Vaccines Location: Waltham, MA About the Job...(when applicable), including quality, relevance to external stakeholders (eg regulatory authorities, medical journals), and scientific validity. We are… more
- Sanofi (Waltham, MA)
- …a real impact on millions of patients around the world. Main Responsibilities: Lead the cross-functional Adjuvant Platform Global Team to deliver the strategy, ... conjugate technologies. A strong matrix leader is required to lead a cross-functional Adjuvant Platform team with the mission...current and future Vaccines portfolio. We are an innovative global healthcare company that helps the world stay ahead… more
- Sanofi (Waltham, MA)
- …accurate assessments are made for decision-making, while ensuring compliance with regulatory expectations. Main responsibilites Acts as the lead statistician ... head of Preclinical or Non-Clinical Team and/or the TED Global head who are all part of the ...the senior manager of the TED team or Research lead , participates in project activities such as assist in… more
- Takeda Pharmaceuticals (Boston, MA)
- …medicines and make a lasting impact on patients worldwide. Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part of the ... readiness for high-impact oncology programs. **How you will contribute:** + Lead global regulatory strategy for assigned programs across development stages.… more
- Takeda Pharmaceuticals (Boston, MA)
- …medicines and make a lasting impact on patients worldwide. Join Takeda as Associate Director, Global Regulatory Lead Oncology where you will be part of the ... global regulatory team. As Associate Director, Global Regulatory Lead Oncology, you will define and lead global regulatory strategies for… more
- Takeda Pharmaceuticals (Boston, MA)
- …medicines and make a lasting impact on patients worldwide. Join Takeda as a Director, Global Regulatory Lead Oncology where you will be part of the ... global regulatory team. As Director, Global Regulatory Lead Oncology you will set global regulatory strategy and lead major submissions… more
- Rhythm Pharmaceuticals (Boston, MA)
- …shaping and steering regulatory direction to support program success. As the Global Regulatory Lead , you will oversee your assigned programs, ensuring ... cycle management of Rhythm products. Responsibilities and Duties + Act as the Global Regulatory Lead within the cross-functional core team. + Contribute to… more
- Sanofi Group (Framingham, MA)
- … assessment for medical devices Due Diligence activities as applicable May serve as Device Global Regulatory Lead (dGRL) leading a Device GRT, which includes ... **Job title** : Global Regulatory Affairs Device Lead (Associate Director) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job**… more
- Takeda Pharmaceuticals (Boston, MA)
- …opportunities. + Partner with global market access colleagues to lead interactions with joint regulatory /health agency/HTA bodies on product specific ... my knowledge. **Job Description** **_Objective / Purpose:_** + Defines, develops and leads global strategies to maximize global regulatory success towards… more
- Takeda Pharmaceuticals (Boston, MA)
- …Management** + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... order to bring life-changing therapies to patients worldwide. Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the… more
- Takeda Pharmaceuticals (Boston, MA)
- …Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... to bring life-changing therapies to patients worldwide. Join Takeda as Senior Manager, Global Regulatory Labeling Strategy where you will be responsible for the… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …submissions and manages lifecycle activities for all assigned projects in alignment with the Global Regulatory Lead . Translates complex pertinent global ... submissions and manages lifecycle regulatory activities in alignment with the Global Regulatory Lead (GRL). - Identifies the need and obtains … more
- Takeda Pharmaceuticals (Boston, MA)
- …application is true to the best of my knowledge. **Job Description** RPM&SP partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams ... planning _._ The intern will support the Gastrointestinal (GI) Global Regulatory Project Management & Strategic Planning...efficiently. The intern contribution will help in assisting the lead RPM to focus on strategy while ensuring operational… more
- Sumitomo Pharma (Boston, MA)
- …project(s) in line with the global registration strategy of the product + Supports the global regulatory lead (GRL) and the CMC regulatory lead ... Affairs (Oncology).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based in...Lead , manage regional (United States, European and/or ROW) regulatory activities as part of a Global … more
- Parexel (Boston, MA)
- …across global markets? Parexel is seeking an experienced and highly motivated ** Global Regulatory Labeling Lead ** to provide strategic leadership and ... Label Profile. + Align labeling content and strategy across US, EU, and global regulatory teams; facilitate timely endorsement of labeling decisions by senior… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …regulatory guidelines and perspective to the cross-functional team. Serve as CMC regulatory lead on global project teams (Pharmaceutical Development, ... **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is... submissions, and post-marketing lifecycle management as the CMC Regulatory lead . + Regulatory experience… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **OBJECTIVES/PURPOSE:** Reporting to the Head, Global Regulatory Operations (GRO), the Head of Global ... system reach and adoption, and enhancing efficiency through data connectivity across Global Regulatory Affairs (GRA), Research & Development (R&D), and the… more
- Oracle (Boston, MA)
- …to make informed decisions, streamline processes, and drive better health outcomes. As Lead Product Regulatory Strategist, you will be responsible for analyzing ... of Oracle Health products with applicable compliance deadlines. **Responsibilities** The Lead Product Regulatory Strategist role involves leveraging expertise in… more
- Wolters Kluwer (Waltham, MA)
- ** Regulatory Initiatives Product Manager** Wolters Kluwer is a global leader in professional information and software solutions, trusted by clinicians and ... of healthcare. This is a product management role focused on integrating regulatory and compliance considerations into product strategy and development. **It is not… more
- Takeda Pharmaceuticals (Boston, MA)
- …etc.) in response to global pharmacovigilance user requirements and/or regulatory guidance; Lead and perform user needs and requirements analysis, ... of requirements, designs, source code development, unit testing, maintenance, and migration; Lead and execute tuning and optimization of Global reporting… more
