- Takeda Pharmaceuticals (Boston, MA)
- …the meetings and tracking of required actions until completion + Monitor progress toward Global Regulatory Affairs KPIs, intervening as necessary to ensure ... organization to advance the objectives and vision of the Chief Regulatory Office + Ensure project management...at least one of the following: clinical development, pharmacovigilance, regulatory affairs or clinical supplies + Experience… more
- Sumitomo Pharma (Boston, MA)
- …budget for Oncology clinical development activities. + Partner with Translational Research, Regulatory Affairs , Clinical Operations, and Medical Affairs to ... regulatory authorities, including the FDA, EMA, and other global agencies, to secure trial approvals and navigate the...clinical study reports, and NDA/MAA filings. + Collaborate with regulatory affairs team to ensure compliance with… more