- 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
- AbbVie (Waltham, MA)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Director Regulatory Affairs Global Regulatory Lead , Global Regulatory ... Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory Strategy… 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)
- …our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams ... for assigned programs. **How you will contribute:** + Partnering with the program Global Regulatory Lead (GRL), co- lead and facilitate product-specific … 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
- Sanofi Group (Cambridge, MA)
- … Regulatory Team (GRT) for the Innovation Franchise and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist (RS) will ... thought was possible. Ready to get started? **Main Responsibilities:** + Enables the Global Regulatory Lead (GRL) by providing quality regulatory input… 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
- Fresenius Medical Center (Waltham, MA)
- …products. **PRINCIPAL DUTIES AND RESPONSIBILITIES:** + ** Regulatory Strategy Leadership:** + Lead the development of global regulatory strategies for the ... strategies, and potential risks to inform decision-making across the organization. + ** Global Regulatory Submissions:** + Oversee the planning, preparation, and… 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
- Takeda Pharmaceuticals (Lexington, MA)
- …and approves - as needed - technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. + When in a GRA CMC Product ... Team lead role, prepares and maintains relevant regulatory ...regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and… more
- Fresenius Medical Center (Waltham, MA)
- …in the pharmaceutical or biotechnology industry, with a strong emphasis on global regulatory submissions. + Proven expertise in the preparation, compilation, ... Adobe Acrobat (PDF optimization and troubleshooting). + Strong understanding of global regulatory submission guidance. + Demonstrated experience managing… 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