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AI Summary
Lead the formulation of regulatory strategies for new drug development and serve as the primary contact for regulatory authorities, including the PMDA. Manage the compilation of approval application documents and coordinate with global departments for NDA processes in Japan.
The primary scope of the Regulatory Affairs Department is as follows:
- Formulating regulatory strategies during new drug development phases. Coordinating project teams and serving as the primary contact for regulatory authorities during agency consultations, including PMDA meetings to define regulatory and clinical trial strategies.
- Serving as the primary contact for regulatory authorities during new drug applications, compiling approval application documents (CTDs), and preparing FD applications
- Serving as the point of contact for authorities regarding minor changes and other applications, compiling submission documents, and preparing FD applications.
- Manufacturing site certification, MF, GMP inspection applications, etc.
- Package inserts: New creation and maintenance in collaboration with Pharmaco-vigilance Department
- Drug pricing-related tasks
- CMC regulatory affairs personnel within the department provide support to overseas development centers and manufacturing sites regarding specifications, test methods, manufacturing methods, and manufacturing transfers, and prepare approval application documents.
Requirements
Preferred Education Background
- Bachelor's degree or higher (preferably in life sciences such as chemistry or pharmacy)
Preferred Industry Exposure (if any):
- 10+ years of experience in regulatory affairs at pharmaceutical companies
- Management experience of departments and subordinates within a regulatory affairs department
Preferred Geography Exposure (if any):
- Preferably in the Tokyo metropolitan area (Tokyo, Kanagawa, Chiba, Saitama), but remote work arrangements in other locations are negotiable
Minimum years of experience
- 10+ years of experience in regulatory affairs for new drug development
Critical experience(s) required
- Experience leading regulatory agency consultations such as new drug applications and face-to-face PMDA meetings
- Experience collaborating with global departments to manage NDA application and approval processes in Japan for globally developed drugs
- Business-level English proficiency essential for effective communication via email, phone conferences, and video conferences with global counterparts
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