- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director Global Regulatory Lead , GRAD Oncology. You will provide strategic ... be responsible for complex or highly complex or multiple projects. May lead the Global Regulatory Teams (GRTs) and applicable sub-working groups, such as… more
- Takeda Pharmaceuticals (Boston, MA)
- … strategy and coordinating life cycle activities across the portfolio of PDT products. The Global Regulatory Lead , Director, in PDT R&D: + Serves as the ... global regulatory lead for one or more projects and and includes leadership of the Global Regulatory Team (GRT) composed of core regulatory … more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Global Regulatory Lead **Location** : Morristown, NJ, Cambridge, MA **About the Job** Are you ready to shape the future of medicine? The race ... Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs Lead (GRL) is the fully accountable decision maker for… more
- Takeda Pharmaceuticals (Boston, MA)
- …The Director will lead all submission types. + Accountable for building global regulatory strategies as defined within the GRT and ensure those are ... Description** **Objective / Purpose:** + Defines, develops and leads global strategies to maximize global regulatory...Partner with global market access colleagues to Lead interactions with joint regulatory /health agency/HTA bodies… 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
- 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)
- … Global Regulatory Affairs, Marketed Products with the following duties: Assist the Global Regulatory Lead (GRL) and is accountable for working with ... and executed, ensuring global regulatory compliance; Assist the Global Regulatory Lead with Health Authority meetings and responses; Partner with… more
- Takeda Pharmaceuticals (Boston, MA)
- …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...+ Working within Labeling Team and GRA + Represents Global Labeling at Global Regulatory … more
- Rhythm Pharmaceuticals (Boston, MA)
- … Global Regulatory Affairs. Responsibilities and Duties + Act as the Global Regulatory Lead on multi-disciplinary project teams and provide strategic ... strategies for the program(s) under your accountability. You will lead the regulatory strategy and initiatives for...execution of regulatory filings, maintaining compliance with global regulatory standards and commitments. You will… more
- Takeda Pharmaceuticals (Boston, MA)
- …Management - Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... Serve as the expert for device labeling on the global Regulatory Affairs (RA) Sub team and...Cross-Functional Team (GLOC) - In alignment with TAU/MPD Labeling Lead , coordinates the process to obtain IFU labeling approval… more
- Takeda Pharmaceuticals (Boston, MA)
- …promotion. **How you will contribute:** + As our Associate Director, Global Regulatory Affairs Advertising and Promotion lead you will act as the Subject ... in order to bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review … more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Global Regulatory Affairs Device Head, Specialty Care Device and Combination Products (Sr. Director) **Location** : Cambridge, MA or Morristown, ... be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device Head, Specialty...Device Head, Specialty Care Device and Combination Products will lead a team responsible for device regulatory … 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 ... to bring life-changing therapies to patients worldwide. The Associate Director Global Regulatory Affairs, Neuroscience is responsible for developing innovative… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Lead , Regulatory Data **Location** : Cambridge, MA, Morristown, NJ **About the Job** Are you ready to shape the future of medicine? The race is on ... Lead role is the business owner for the regulatory data migration at an operational level and ensures...of organizational structure and managing expectations with timelines with global colleagues in various functions (eg,. Regulatory … more
- Bristol Myers Squibb (Cambridge, MA)
- …personal lives. Read more: careers.bms.com/working-with-us . The Sr. Director, HRBP for Global Regulatory Strategy and Worldwide Patient Safety in Drug ... fostering team synergy, and spearheading dynamic change management initiatives. Given the global presence of the client group across multiple BMS locations and… 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
- Takeda Pharmaceuticals (Boston, MA)
- …in purpose and be empowered to deliver your best. As part of the Global Medical Affairs Oncology team, you will report to the Scientific Communications Group ... Lead , Hematology. As a subject matter expert on scientific...members of medical affairs, clinical development, and outcomes research; global , regional, or local); leads the publications planning team;… more
- Takeda Pharmaceuticals (Boston, MA)
- …appropriate comparator + Co- lead with Market Access the development of the global value proposition to ensure a compelling value story for payers + Identify and ... Access, Global Evidence and Outcomes, Medica Affairs, Clinical Development, Regulatory Affairs, Biostatistics, Global Emerging Markets (GEM; eg, China),… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …+ Comprehensive understanding of the pharmaceutical industry and medical affairs + Global regulatory expertise with demonstrated strong ability for collaboration ... best of my knowledge. **Job Description** **Role Objectives:** + The Group Lead , Global Scientific Communications has ultimate accountability for delivering and… more
- Pfizer (Cambridge, MA)
- …Insight Strategy & Execution, and all other Enabling Functions. **RESPONSIBILITIES** + Lead all global elements of in-line marketing, commercial development, and ... Prostate Cancer for Pfizer Oncology. + Chair the Talzenna Global Governance Team and lead the co-creation...disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of… more