- Danaher Corporation (Boston, MA)
- …Business Syste m (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Principal, Regulatory Affairs is ... and digital pathology in the clinical oncology environment. The Senior Principal, Regulatory Affairs will...include : + Bachelor's, Master's, or PhD in a scientific or engineering discipline. In-depth working knowledge of FDA… more
- Takeda Pharmaceuticals (Boston, MA)
- …is possible in order to bring life-changing therapies to patients worldwide. The Senior Global Regulatory Affairs , Neuroscience is responsible for developing ... area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively… more
- Hologic (Marlborough, MA)
- Senior Regulatory Affairs Specialist Newark, DE, United States Marlborough, MA, United States United States **Join us as a Regulatory Affairs ... **About the Role:** As a key member of our Regulatory Affairs team, you will be responsible...Looking For:** + Bachelor's degree in a technical or scientific discipline (Master's or RAC certification preferred) + 5-8… more
- Takeda Pharmaceuticals (Lexington, MA)
- …People leadership experience (5+ years) required. + Highly proficient understanding of scientific principles and profound grasp of global regulatory CMC ... + Champions, independently develops and leads the execution of regulatory CMC investigational and/or registration strategies for assigned products...timely manner. Acts as an advisor and liaison to senior management. + As a member of the modality… more
- ConvaTec (Lexington, MA)
- …Certification preferred. **Dimensions:** **Team** Part of a small team. Reporting to Senior Manager - International Regulatory Affairs , additional direction ... responsibilities of the position are to drive improvements in regulatory affairs processes, systems and infrastructure whilst... + Participates as an active member of Industry, Regulatory or Scientific Committees, as appropriate +… more
- Takeda Pharmaceuticals (Boston, MA)
- …probabilities of technical success for the solutions. + Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at ... NDA, 510K, CE Mark submissions and their amendments/supplements). + Understanding of scientific principles and regulatory Device requirements relevant to global… more
- Takeda Pharmaceuticals (Boston, MA)
- …of the Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + Plan, ... and product development meetings, international experience preferred. + Understanding of scientific principles and regulatory CMC requirements relevant to global… more
- Edwards Lifesciences (Boston, MA)
- Patients are at the heart of everything we do. As the Senior Director, THV Medical Affairs , you will drive strategy development, evidence generation initiatives, ... and scientific communication activities to advance key organizational objectives that...vision of the organization + Facilitating effective collaboration across senior leadership stakeholders, including clinical, regulatory , marketing,… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Associate Director, Global Regulatory Affairs Advertising and Promotion **Location** : Cambridge, MA Morristown, NJ **About the Job** Are you ... thought was possible. Ready to get started? **Main Responsibilities:** + Represents Global Regulatory Affairs (US RA AdPromo) as a member of cross-functional… more
- Takeda Pharmaceuticals (Boston, MA)
- …and tracking of required actions until completion + Monitor progress toward Global Regulatory Affairs KPIs, intervening as necessary to ensure that Regulatory ... experience in at least one of the following: clinical development, pharmacovigilance, regulatory affairs or clinical supplies + Experience in R&D operations… more