and immune disorders. Summary: Responsible for leading and developing global regulatory strategy for assigned development... global regulatory strategy is endorsed by GPT and other governance bodies. Serve as a leader of the GRT (Global Regulatory...
. Brings issues with regard to ways or working or resources to the Head of US Regulatory Affairs and/or Global Regulatory Lead... and transparent ways of working across the Alliance within US regulatory affairs and will work closely with the US Regulatory PMs...
across all global projects, securing the cooperation of others (team members); meet aggressive deadlines to ensure that regulatory... Experience Qualifications 7 or More Years in the pharmaceutical industry 4 or More Years in regulatory affairs, NDA, sNDA, BLA...
to Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical... Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational...
Pharmacovigilance Practice and regulatory compliance in such arrangements. Oversees Local/Global Pharmacovigilance (PV) service..., and proactively drive operational excellence and continuous improvement. Oversees the management of Global PV Regulatory Intelligence...
Regulatory affairs in providing content and providing review of documents supporting CDx submissions to the FDA and other health..., under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo...
and immune disorders. We are currently seeking a Global Oncology Medical Affairs (GOMA) Publications Intern for summer 2025... Publications team within Global Oncology Medical Affairs (GOMA) is seeking a Publications Systems and Operations Intern to work...