- Unknown (Boston, MA)
- …expertise and guidance to the client contact for CMC development teams. The Director will also lead regulatory intelligence activities, monitoring changes ... The Director will collaborate cross-functionally with internal teams to...pharmaceutical products. They will have a deep understanding of global regulatory requirements and a track record… more
- Sanofi (Cambridge, MA)
- Job Title: Director , US Regulatory Affairs - Advertising and Promotion (Hybrid) Location: Cambridge, MA Morristown, NJ About the Job Are you ready to shape the ... Your skills could be critical in helping our teams accelerate progress. As the Director , US Regulatory Affairs - Advertising and Promotion, you'll partner with… more
- Sanofi (Cambridge, MA)
- …project under the leadership of the Global Project Head, with the Global safety Officer, Regulatory Strategist and other key functional representatives to ... Job Title: Senior Clinical Research Director Location: Cambridge, MA or Morristown, NJ About...RARE Therapeutic Area, you will be the expert clinical lead for one or several indications in the Development… more
- Pfizer (Cambridge, MA)
- …between the study team, investigators, ethics committees, steering committees, and regulatory authorities. Lead and contribute to development and maintenance ... preferred Breast Oncology experience (2+ years) Organizational Relationships Reports to Global Development Lead and partners closely with subject matter… more
- The Computer Merchant, LTD. (Waltham, MA)
- …managing complex SAP systems and SOx controls. This role reports directly to the Global Financial Systems and ERP Director . Key Responsibilities: * Oversee the ... within the teams, ensuring milestones are met and projects remain on track. * Lead and inspire a diverse team of approximately 15 employees across the US and… 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 … more
- Takeda Pharmaceuticals (Boston, MA)
- …to transformative 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 … 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 ... 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)
- …opportunities. + Partner with global market access colleagues to lead interactions with joint regulatory /health agency/HTA bodies on product specific ... Description** **_Objective / Purpose:_** + Defines, develops and leads global strategies to maximize global regulatory...oversees direct reports or other staff responsible. The Senior Director will lead all submission types. +… more
- Bristol Myers Squibb (Cambridge, MA)
- …diligence and business development assessments. + Working with regional regulatory staff as Global Regulatory Lead and US Regional Regulatory Lead ... both at work and in their personal lives. Read more: careers.bms.com/working-with-us . **Sr Director , Global Regulatory Strategy, Neuroscience** + Will be a… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …**How you will contribute:** + As our Associate Director , Global Regulatory Affairs Advertising and Promotion lead you will act as the Subject Matter ... possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA ... GRA A&P SME for assigned products and projects. + Regulatory advisor as the "R" in the core Medical,...review, approval, and implementation + Product or project business lead for global CMRP at Takeda +… more
- Sanofi Group (Cambridge, MA)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director ) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the ... for medical devices Due Diligence activities as applicable May serve as Device Global Regulatory Lead (dGRL) leading a Device GRT, which includes the… more
- Takeda Pharmaceuticals (Boston, MA)
- …our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams ... empower you to shine? Join us as an Associate Director , Global Regulatory Project Management...**How you will contribute:** + Partnering with the program Global Regulatory Lead (GRL), co-… 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
- Takeda Pharmaceuticals (Boston, MA)
- …development of scientific communications strategy and deliverables, the **Associate Director , Scientific Communications Lead , Hematology** proactively defines ... empowered to deliver your best. As part of the Global Medical Affairs Oncology team, you will report to...life sciences, and excellent project management skills. The Associate Director , Scientific Communications Lead , develops and implements… more
- Takeda Pharmaceuticals (Boston, MA)
- …Management + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more
- Takeda Pharmaceuticals (Boston, MA)
- …Autonomy + Responsibility in line with Associate Director level position; independently lead HE projects and support the Global Health Economics Center of ... appropriate comparator + Co- lead with Market Access the development of the global value proposition to ensure a compelling value story for payers + Identify and… more
- Bristol Myers Squibb (Cambridge, MA)
- …. **Position Summary** The Director of Early Precision Medicine Regulatory Affairs leads global regulatory strategy for biomarkers ... Drive the development and actively support the execution of innovative, compliant global regulatory strategies that enable cutting-edge biomarkers and diagnostic… 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 ... 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
