- GRAIL (Boston, MA)
- … plans and activities to optimally position GRAIL products with the FDA and/or global health authorities. + Support the US Regulatory Affairs team in preparing ... North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information,… more
- CSL Behring (Waltham, MA)
- …position and is onsite three days a week. You will report to the Director of Clinical Assay. **Position Description Summary:** You will be part of a specialized ... data sets to meet the business needs. Deep understanding of assay design, regulatory standards and industry best practices are essential. The incumbent will have a… more
- Parexel (Boston, MA)
- …and ability to gain command of process details + Demonstrated knowledge of global and local regulatory requirements + Demonstrated understanding of key ... **Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is responsible for the site...development and checks, when applicable **Collaboration** + Reports to Director of Clinical Site Operations (DCSO) or Director… more
- Parexel (Boston, MA)
- …of experience will be required for the more senior roles of Senior Project Leader, Associate Project Director , and Project Director . To excel in this role, ... for our clients and advancing clinical research projects. As a part of the Global Project Leadership organization, your work has a direct impact on the projects,… more
- Takeda Pharmaceuticals (Boston, MA)
- …to transformative 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 (Cambridge, MA)
- …what is possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and ... to prescription medicine promotion. **How you will contribute:** + As our Associate Director , Global Regulatory Affairs Advertising and Promotion lead… more
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **Job Description** **Objective / Purpose:** + Defines, develops and leads global strategies to maximize global regulatory success towards ... + Provides leadership and development for direct reports, including those that serve as global regulatory leads responsible for the design and execution of … more
- Sumitomo Pharma (Boston, MA)
- …of ** Associate Director , Regulatory Affairs (Oncology).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based in ... the US. He/She will primarily function as a regional regulatory leader (RRL) and/or Global Regulatory Leader (GRL) for assigned products. This position is… 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 ... Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse team supporting the… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Director Global Regulatory Affairs, Neuroscience is responsible for ... developing innovative global regulatory strategies and providing strategic regulatory guidance...direct reports or junior colleagues executing these tasks. The Associate Director will lead highly complex submission… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- The Associate Director of Regulatory Intelligence leads the collection and dissemination of regulatory intelligence and collaborates with SMEs to ... environment. **Job Description** + Oversee the capture, review, and dissemination of global regulatory news, public commenting opportunities, new and updated… more
- Takeda Pharmaceuticals (Boston, MA)
- …the development of scientific communications strategy and deliverables, the ** Associate Director , Scientific Communications Lead, Hematology** proactively ... empowered to deliver your best. As part of the Global Medical Affairs Oncology team, you will report to...in life sciences, and excellent project management skills. The Associate Director , Scientific Communications Lead, develops and… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be ... escalates issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk mitigation strategies for assigned products… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Job Summary** The Associate Director , Quality Operations will lead initiatives that drive operational excellence, enhance risk management practices, and ... practices. **Compliance & Governance** + Ensure quality operations comply with global regulatory requirements (eg, FDA, EMA, PMDA) and internal standards. +… more
- RTX Corporation (Boston, MA)
- …Services Process and Systems Transformation (PST) Team:** RTX has an opening for an ** Associate Director , Global Trade - Compliance and Supply Chain (S2P)** ... ( Associate Director , Global Trade) position. **Exciting Opportunity to...Corporate and RTX business units** operating across a complex regulatory and systems landscape + Travel 20-25% **Qualifications You… more
- Takeda Pharmaceuticals (Boston, MA)
- …GMSci DP/PKG** **Location: Cambridge, MA** **About the role:** As a Process Scientist ( Associate Director ) - Global Manufacturing Science GMSci Drug Product ... Sciences. + Manufacturing Sciences + Global Manufacturing Supply, Global Quality and Global Regulatory Affairs. + SME for Takeda drug product… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Job Summary** The Associate Director , Global Product Quality - Biologics is responsible for directing quality oversight of clinical and commercial products ... and transported in a controlled way that is in accordance with regulatory expectations and applicable cGMP/GDP quality standards. This role will direct Biologics… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Job Summary** The Associate Director Controlled Substances, Quality Global Product Quality - API/DP is responsible for directing quality oversight of ... are manufactured, packed, labelled, stored, and transported accordance with regulatory expectations and applicable cGMP/GDP quality standards. This role has… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …assigned compounds to drive alignment of labeling content and strategy. + Partner with Global Regulatory Affairs to ensure that all labeling is aligned with the ... activities related to all global labeling components. + Represent Global Labeling on product-specific Regulatory and Cross-Functional teams, as appropriate.… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Summary:** The Global Integrated Evidence Operations, Associate Director role oversees and coordinates the operational processes, digital system support, ... and governance for Global Integrated Evidence & Innovation (GIE&I), which includes responsibility...development lifecycle functions such as Discovery, Clinical Trials, and Regulatory . + Experience with digital technology to support management… more
