Save Job Back to Search Job Description Summary Similar Jobs日本法人の立ち上げ・拡大フェーズで、薬事機能の構築から将来的なチームマネジメントまで携われるAPAC・オーストラリアを含むグローバルチームと連携し、日本市場の成長に大きな裁量を持って関われるAbout Our ClientWe are a global CRO (Contract Research Organization) that supports clinical development, primarily for biotech companies. While we specialize in oncology, we also serve a wide range of therapeutic areas.Job Description- Responding to PMDA consultations and handling regulatory-related tasks.- Support from a regulatory perspective during discussions with sponsors- Project promotion related to regulatory strategy and regulatory operations- Management of ICCC Management and related operations- Review and management of pharmaceutical-related documents such as CTD and CTN.- Participation in and proposals from a regulatory perspective in business development activities.- Collaboration with global teams, sponsors, and internal stakeholders- Building a future Regulatory team and line managementThe Successful Applicant【must】* Practical experience in Regulatory Affairs/Regulatory Operations at a CRO* Experience at PMDA ConsultingBusiness-level English proficiency【welcome】* ICCC Management experience* Experience in CTD/CTN-related work- Experience in pharmaceutical consulting for SRs- Experience in providing regulatory support to business development/sales activities.* Experience participating in global projectsWhat's on Offer- Tokyo office / Hybrid work arrangements- Opportunity to participate in the establishment and organizational expansion phases of the Japanese subsidiary.Collaboration with global teams- A high degree of autonomy and speed that is difficult to obtain at large CROs* Career paths to future team building and line managementContactHana HaradaQuote job refJN-082026-7092961Phone number+81 3 6832 8602Job summaryFunctionLife SciencesSpecialisationRegulatory AffairsSpecialisationHealthcare / PharmaceuticalLocationTokyo 23 WardsJob TypePermanentConsultant nameHana HaradaConsultant phone+81 3 6832 8602Job ReferenceJN-082026-7092961Company TypeForeign MultinationalWork from HomeWork from Home or Hybrid
