- Cipla (Fall River, MA)
- …posting for local applicants only - is not for those applying for a global assignment and/or for employees working outside of Cipla's US Subsidiaries or Affiliates. ... About Cipla Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded, and generic...highly visible individual contributor role that reports to the Director of Project Management, R&D, North America. The job… more
- 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
- 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
- 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 (Framingham, 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)
- …Management** + Appropriately escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies ... possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will be… 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
- Sumitomo Pharma (Providence, RI)
- …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
- Rhythm Pharmaceuticals (Boston, MA)
- … Global Regulatory Affairs. Responsibilities and Duties + Act as the Global Regulatory Lead on multi-disciplinary project teams and provide strategic ... to overcome barriers, together. Opportunity Overview In the Associate Director , Regulatory Affairs role, you will be...execution of regulatory filings, maintaining compliance with global regulatory standards and commitments. You will… more
- Otsuka America Pharmaceutical Inc. (Providence, RI)
- …environment. **Job Description** + Oversee the capture, review, and dissemination of global regulatory news, public commenting opportunities, new and updated ... + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory...assessments of new or updated guidance and regulations. + Lead regulatory public commenting process and posting… more
- Otsuka America Pharmaceutical Inc. (Providence, RI)
- …post commercialization, with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director , GCD is responsible for all ... and clinical trial implementation and management. + Complete understanding of the global regulatory requirements. + Working knowledge of marketing and… more
- Lilly (Boston, MA)
- …Strategy role is to support the development and implementation of innovative global regulatory strategies for preclinical and early clinical development ... to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work… more
- Otsuka America Pharmaceutical Inc. (Providence, RI)
- …Actions (CAPA), Deviations, and Change Control** , ensuring compliance with global regulatory requirements and internal standards. The successful candidate ... **Job Summary** The Associate Director , Global Product Quality - GMP...Competencies: + Strong knowledge of GMP, ICH guidelines, and global regulatory requirements. + Strong analytical skills… more
