- Leica Biosystems (Boston, MA)
- …oncology environment. The Senior Principal, Regulatory Affairs will provide oversight and lead global submission work including in support of CDx trials and ... agencies on new product development and strategic initiatives to lead the regulatory activities for global commercialization. This position reports to… more
- 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:** Cambridge, MA , Morristown, NJ **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 Lead (GRL) is the fully accountable decision maker for the… 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 ... providing operational support for assigned programs. + Partnering with the program Global Regulatory Lead (GRL), co- lead and facilitate product-specific … 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)
- …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
- AbbVie (Waltham, MA)
- …Team (GRPT). Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers. May lead the Labeling Regulatory ... . Job Description The Director, Oncology Business Development and Global Regulatory Strategy is responsible for developing...Sr GRL or TA Head. May participate in or lead regulatory and Company initiatives. Based on… 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)
- …labeling claims. + Represent Global Labeling on global regulatory teams and labeling sub-teams; lead labeling-related discussions and decision-making. + ... **Job Title:** Director, Global Regulatory Affairs - Global...was possible. Ready to get started? **Main Responsibilities** + Lead the development, maintenance, and alignment of global… more
- Philips (Cambridge, MA)
- …of all Software/Artificial Intelligence platforms for the Ultrasound business. **Your role:** + Lead a global Regulatory Affairs team for end-to-end ... Affairs- Software and Artificial Intelligence (Ultrasound)** The Director, Regulatory Affairs-SW and AI will lead the...the hiring and development of critical talent within the global regulatory affairs team through creating and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Design (AQbD) principles, aligning with ICH Q14, ICH Q2(R2), and global regulatory expectations for biologics. + Lead technical assessments and risk analyses ... control strategies. + Solid knowledge of late-stage analytical development, including global regulatory requirements for Biologics (US, EU, Japan, China).… 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)
- …Proactively recognizes and contributes to enhancing business processes. As part of the Global Regulatory Affairs CMC team, you will report to the Senior ... Director Global Regulatory Affairs CMC. **How you will...Authorities, as required. + Proven ability to liaise with Regulatory Agencies, having served as lead in… 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 ... in order to bring life-changing therapies to patients worldwide. The Director Global Regulatory Affairs, Neuroscience is responsible for developing innovative … 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 (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
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director, Global Regulatory Affairs - Global Labeling Strategy **Location** : Morristown, NJ or Cambridge, MA (Hybrid) **About the ... in helping our teams accelerate progress. The Associate Director, Global Regulatory Affairs - Global ...was possible. Ready to get started? **Main Responsibilities** + Lead the preparation, review, and maintenance of global… more
