- 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
- Merck (Boston, MA)
- … Affairs , General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of Our ... in industry regulatory compliance. The Vice President Regulatory Affairs , General Medicine is accountable for:...Key Accountabilities: + Directs activities of the General Medicine global regulatory therapeutic area and team leading… more
- Sumitomo Pharma (Providence, RI)
- …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