メディカル・バイオ - 薬事申請

This role serves as the primary contact for regulatory strategy in Japan, ensuring smooth interactions with PMDA/MHLW and alignment with global teams. Key responsibilities include providing Japan-specific input, preparing and submitting regulatory documents, managing CTD modules, overseeing inspections, and supporting post-market regulatory activities. The position also fosters cross-functional collaboration, manages consultants, collects regulatory intelligence, and ensures compliance in co-promotion settings.

■休日：完全週休二日制, 土, 日, 祝日, 年末年始

Education / Certifications:
• Bachelor’s degree in Natural Sciences
• Pharmacist is preferable.

Experiences
• Experience within the Pharmaceutical industry or CRO
• Minimum 3 years Regulatory Affairs Experience in Pharmaceutical industry or CRO
• Successful creation and submission of CTD dossiers.
• Experience with the PMDA interactions.
• Experience of neuroscience and/or psychiatry field are preferable

■職種未経験者：不可