- Fresenius Medical Center (Waltham, MA)
- …May be responsible for the direct supervision of various levels of Regulatory Affairs Operations staff. **EDUCATION:** Bachelor's Degree required; Advanced ... **PURPOSE AND SCOPE:** Oversees all regulatory activities for new and mature products to...applications, IND/ODA annual reports, amendments) in the electronic format ( eCTD and eFiling). + Develops, implements and maintains various… more
- Takeda Pharmaceuticals (Boston, MA)
- … Regulatory Project Management and Strategic Planning - GI2 TAU within our Global Regulatory Affairs organization, based remotely. + Partners with the ... changes through proactive engagements with cross functional team members, Global Regulatory Affairs TAU colleagues...and process is required. + At least two major eCTD (original or supplement) registrations and several minor (amendment)… more