- 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
- Parexel (Boston, MA)
- …are expanding our esteemed Medical Sciences Team and seeking an Associate /Medical Director to support the growth of our Global Immunology and Inflammation ... Therapeutic Franchise. As an Associate / Medical Director , you will work closely with some of the...needed with the support of the designated Senior Medical Director / Global Head of TA (as appropriate)… 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
- CSL Behring (Waltham, MA)
- …a hybrid position and is onsite three days a week. You will report to the Director of Clinical Assay. You will be part of a specialized non-laboratory based team and ... 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 (Framingham, 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
- 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
- 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)
- The Associate Director of Global Supplier Quality will be responsible for the execution of supplier quality audit and monitoring across the company's ... quality issues. + **Compliance & Documentation** + Ensure supplier compliance with global regulatory requirements (eg, FDA, EMA, ICH). + Prepare documentation… 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
