求人を保存 検索に戻る 職務内容 求人情報 類似した求人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企業情報We 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.職務内容- 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 management理想の人材【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 projects条件・待遇- 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 managementコンタクトHana Harada求人番号JN-082026-7092961電話+81 3 6832 8602求人情報分野ライフサイエンス職種薬事・学術業界ヘルスケア・製薬勤務地東京23区雇用形態正社員担当コンサルタントHana Harada担当コンサルタントの電話番号+81 3 6832 8602求人番号JN-082026-7092961企業タイプ外資系企業勤務形態在宅可・ハイブリッド勤務可
