- Takeda Pharmaceuticals (Cambridge, MA)
- …products within the US Market. You will report to the Head Counsel, Takeda Global Oncology, and you will work very closely with your Oncology Business Unit Clients. ... as counsel for our Government Price Reporting function concerning legal, regulatory , and compliance issues associated with federal government price reporting… more
- Bristol Myers Squibb (Devens, MA)
- …with regulatory requirements. Serve as the Cell Therapy compliance lead during GCP inspections, providing expertise and support for manufacturing IP ... Operations, and Franchise, ensuring ongoing monitoring and reporting to maintain regulatory compliance. + Work collaboratively with Global Quality Governance… more
- Sanofi Group (Cambridge, MA)
- …with the Device Regulatory Lead on assigned projects + Provide regulatory guidance and advice to Global Regulatory Team (GRT) and cross-functional ... be critical in helping our teams accelerate progress. The Global Regulatory Affairs (GRA) Device team is...proposed product changes + May serve as a regional/local regulatory lead and point of contact with… more
- Takeda Pharmaceuticals (Boston, MA)
- …(eg TGRD and TPNA/TPEU/TPC). Lead TGRD internal teams and may lead global cross-functional teams, as appropriate. + Hires, manages, mentors, motivates, ... **Knowledge** + Therapeutic area knowledge relevant to mechanism of action + Regional/ global Regulatory requirements + GCP/ICH + Emerging research in designated… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …divisions (eg TGRD and TPNA/TPEU/TPC). Lead TGRD internal teams and may lead global cross-functional teams, as appropriate. + Hires, manages, mentors, ... of action + Knowledge of Hematology and/or Rare Disease is desirable + Regional/ global Regulatory requirements + Emerging research in designated therapeutic area… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …R&D USBU; GPLS, JPBU). Lead R&D internal teams and may lead global cross-functional teams, as appropriate. **EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:** ... + Therapeutic area knowledge + Pulmonologist/Neurologist with sleep medicine expertise + Regional/ global Regulatory requirements + GCP/ICH + Emerging research in… more
- Pfizer (Cambridge, MA)
- …change management, and digital transformation within clinical research. + Experience with global I&I regulatory submissions and interactions with major ... pivotal leader driving the company's clinical innovation and excellence across Pfizer's global I&I portfolio. Reporting to the Chief Development Officer for I&I,… more
- Amgen (Cambridge, MA)
- …and implement strategy for commercial drug product programs, life-cycle management, global regulatory submissions, and variation management for biologics, ... key messages relative to diverse audience requirements + Knowledge of applicable global regulatory requirements. Experience preparing technical sections of … more
- Lilly (Boston, MA)
- …preparation for FDA communication and resolution of regulatory issues, including regulatory response, from a global perspective. + Participate in face to ... 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
- Bristol Myers Squibb (Devens, MA)
- …Quality and serve as a key leader within the GCTQ Organization. This role will lead a global team of quality professionals focused on ensuring the highest ... (QMS), and Planning, Scheduling, Warehouse & Logistics workstreams. **Key Responsibilities** + Lead and develop a global quality organization to support… more