- Lundbeck (Deerfield, IL)
- Director US Regulatory Global Strategic Labelling Requisition ID: 7137 Location: Deerfield, IL, US Do you want to join a team where the mission is meaningful, ... Opportunity - open to candidates in the greater United States** **SUMMARY:** The Director , US Regulatory Affairs Global Strategic Labelling will lead and oversee… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** The Associate Director , Global Regulatory Project Management (AD, Global RPM) is a strategic leader responsible for translating and ... executing regulatory strategies across the global drug development lifecycle. This...with senior stakeholders and cross-functional teams (clinical, medical, safety, CMC , commercial) across regions to achieve strategic business goals… more
- Amgen (Washington, DC)
- …10 million patients worldwide. It's time for a career you can be proud of. Regulatory Policy and Intelligence - US Director **Live** **What you will do** Let's ... do this. Let's change the world. Global Regulatory Policy team engages regulators, industry and professional associations, and patient advocates externally and… more
- Sanofi Group (Morristown, NJ)
- **Job title** : Global Regulatory Affairs Device Lead (Associate Director ) **Location** : Morristown, NJ or Cambridge, MA or Framingham, MA **About the Job** Are ... critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is a globally diverse...of products. The team is part of the GRA CMC & GRA Device Department within Global R&D. The… more
- Lilly (Indianapolis, IN)
- …global regulatory climate and emerging requirements; ability to address key CMC regulatory questions that enable clinical studies and support marketing ... concept) to product commercialization + Experience in development / CMC including quality and regulatory interactions is...in development / CMC including quality and regulatory interactions is expected + Experience with technical transfer… more
- Bristol Myers Squibb (Devens, MA)
- …to ensure product quality, compliance and supply. + Author, review and approve regulatory CMC submission sections. + Drive continuous improvement initiatives to ... influencing external partnerships (CDMOs/CMOs) to achieve strategic outcomes. + Knowledge of CMC regulatory , drug substance & drug product manufacturing, and… more
- Lilly (Indianapolis, IN)
- …highly desirable. + Experience working with ADC projects, especially regarding the unique CMC and regulatory considerations, is a plus. + Strong leadership ... of ADCs, we are seeking a highly experienced and strategic Senior Director to lead our payload linker development efforts within the Antibody-Drug Conjugate… more
- AbbVie (Irvine, CA)
- …+ Author and review CMC analytical sections of BLA and other CMC regulatory packages. Develop strategies for addressing health authority inquiries. + Provide ... supports manufacturing, process transfer/optimization/characterization/validation, analytical method transfer/optimization/validation, product characterization, regulatory submission, and continuous improvement for late-stage and commercial… more
- AbbVie (North Chicago, IL)
- …automation systems strategy and roadmap in alignment with department objectives and SM CMC R&D strategies. . Develop and revise project plans and budgets, work with ... . Provide guidance, technical advice, planning, and project management within SM CMC and with outside functions, consultants, and vendors. Support to laboratory… more
- Takeda Pharmaceuticals (Boston, MA)
- …we do begins with our commitment to putting patients first. As the Director , Technology Business Partner for Pharmaceutical Sciences R&D Data Digital and Technology ... as a strategic advisor and technology domain expert for Pharmaceutical Sciences/ CMC scientific and clinical manufacturing informatics and digital solutions +… more