PSI CRO
pharmaceutical
RegulatoryOfficer
“Regulatory Officer at PSI CRO. Skills: Regulatory affairs, Clinical trials, PMDA submissions. Prepare clinical trial regulatory submission dossiers. Track regulatory project documentation flow”
Industry & Context.
problem-solving skills
What They're Looking For.
Must Have
University degree in Life Sciences, Medicine or Pharmacy or an equivalent combination of education, training, and experience, Experience with clinical trial submissions to PMDA, Knowledge of the regulatory environment for clinical research, Full working proficiency in English and Japanese
Nice to Have
Detail-oriented, Communication (Japanese and English), collaboration, problem-solving skills
What You'll Do.
Prepare clinical trial regulatory submission dossiers
Track regulatory project documentation flow
Review translations of essential documents
Liaise with project teams for documents
Communicate with regulatory authorities
Track legislative changes for clinical trials
Review documents for IP release
Manage safety reporting to authorities
Deliver training on regulatory environment
Participate in regulatory aspects of feasibility research
How You'll Work.
Team & Collaboration
Work closely with our global team of experts; Liaise with project teams; Communicate with sponsors and vendors
Communication Scope
Full working proficiency in English and Japanese; Communication (Japanese and English)
Process & Methodology
Track regulatory project documentation flow and progress reporting
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