- 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)
- …in a Regulatory Operations role. + Knowledge expert regarding global regulatory submission standards, software validation concepts, and publishing best ... special care and consumer-facing self-care). We are proud to be the largest global pharmaceutical group to be awarded **B Corp Certification** , a recognition of… more
- Takeda Pharmaceuticals (Boston, MA)
- …Regulatory Project Management and Strategic Planning - Neuroscience TAU within our Global Regulatory Affairs organization, based remotely. + Partners with ... 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
- Rhythm Pharmaceuticals (Boston, MA)
- …Team. This is a highly visible role with excellent career development opportunities within Global Regulatory Affairs . The position reports into the Director, ... Global Regulatory Affairs . Responsibilities and Duties Submission &...internship experience within a graduate-level degree program) + Requires eCTD knowledge + RAC certification desirable + Knowledge of… 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