- Fresenius Medical Center (Waltham, MA)
- …AND SCOPE:** Assists in the support of the daily operational activities within Regulatory Operations for the preparation of regulatory submissions required to ... RESPONSIBILITIES:** + A seasoned, experienced professional with a full understanding of Regulatory Operations; resolves a wide range of issues in creative ways. +… 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
- Astellas Pharma (Westborough, MA)
- …global CMC regulatory strategy. Works closely with other individuals/groups within Astellas global Regulatory Affairs and with local and global ... a key global leadership role in the Regulatory Affairs department for the Chemistry, Manufacturing...consistency and quality across regions including detailed input on eCTD Module 3 documents for clinical trial and registration… more