- Fresenius Medical Center (Waltham, MA)
- …AND SCOPE:** Assists in the support of the daily operational activities within Regulatory Affairs for the preparation of regulatory submissions required ... AND RESPONSIBILITIES:** + A seasoned, experienced professional with a full understanding of Regulatory Affairs ; resolves a wide range of issues in creative ways.… more
- Chiesi (Boston, MA)
- Manager, Regulatory Affairs Operations, Rare Diseases Date: Jan 10, 2025 Department: GRD Regulatory Affairs Job Type: Direct Employee Team: R&D, ... Pharmacovigilance & Regulatory Affairs Contract Type: Permanent Location: Boston,... Regulatory Operations role. + Knowledge expert regarding global regulatory submission standards, software validation concepts,… 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
- Novo Nordisk (Lexington, MA)
- … submissions, which may include: + Clinical summary and overview documents in eCTD format for global regulatory submissions, including investigational ... About the Department Our East Coast Global Development Hub brings together the best minds...teams, including Medical & Science, Clinical Operations, Biometrics, and Regulatory Affairs personnel, to manage preparation of… more
- Novo Nordisk (Lexington, MA)
- …personnel from Medical & Science, Clinical Pharmacology, Biostatistics, Clinical Operations, Regulatory Affairs , Global Safety, Data Management, and ... Therapy Designation requests + Clinical summary and overview documents in eCTD format for global regulatory submissions + Shares knowledge and experience to… more