Key Responsibilities
The regulatory affairs department is responsible for the following areas:
Formulation of regulatory strategies during new drug development. Lead PMDA consultations such as face-to-face meetings to define regulatory and clinical development strategies, and act as the liaison with authorities.
Act as the point of contact for regulatory authorities during new applications; compile submission documents and prepare FD application forms.
Handle variation applications (partial and minor changes), coordinate submission materials, and prepare FD application forms.
Manage tasks related to site certification, Master File (MF), and GMP inspections.
Collaborate with the safety department to create and maintain package inserts.
Handle tasks related to drug pricing.
The department’s CMC regulatory personnel will support overseas development centers and manufacturing sites regarding specifications, test methods, manufacturing processes, and tech transfers, and will prepare documents for submission.
Key Result Areas / Key Performance Indicators / Weightage
1. NDA submission and approval for new and generic drugs – 35%
Prepare CTD and other submission materials based on global development/regulatory documents and domestic clinical study reports.
Draft responses to PMDA inquiries in collaboration with global and domestic teams.
Handle regulatory review processes, including panel discussions.
Obtain marketing authorizations.
2. Lead regulatory strategy planning for clinical trials and NDA – 30%
Coordinate with internal stakeholders (clinical development, project management) and align strategies with global regulatory teams.
Lead PMDA consultations to agree on the required clinical and approval data based on ICH guidelines.
Finalize clinical development plans in alignment with PMDA.
Lead regulatory strategy planning not only for PMDA consultations but also broadly across new and generic product development.
3. Post-marketing change control and package insert maintenance – 20%
Lead interactions with regulatory authorities and documentation preparation for change control, such as minor change notifications and partial change applications.
Lead GMP inspections, MF submissions, and site certifications.
Create and maintain package inserts in collaboration with the safety department.
4. Educate global development teams on Japan’s regulatory framework – 15%
Understand and stay updated on Japanese regulatory requirements and guidelines.
Communicate necessary information to overseas teams and provide education as needed.
Key Interactions
Internal Stakeholders:
Clinical Development, Project Management, Business Development, Quality Assurance, Supply Chain Management (Japan)
Global development centers and manufacturing sites within the group
External Stakeholders:
MHLW, PMDA, domestic and overseas manufacturing sites, regulatory consultants
Ideal Experience and Required Skills
Preferred Education:
Bachelor’s degree or higher (Life science background such as pharmacy, chemistry preferred)
Preferred Industry Background:
10+ years of experience in regulatory affairs in a pharmaceutical company
Experience managing a regulatory team and direct reports
Preferred Location:
Tokyo area preferred (Tokyo, Kanagawa, Chiba, Saitama), but remote work is negotiable
Minimum Required Experience:
10+ years in regulatory affairs related to new drug development
Critical Experience Requirements:
Proven leadership in PMDA consultations and new drug applications
Experience working with global teams on Japan regulatory submission and approval processes
Business-level English (email, teleconferences, video meetings) required for communication with global stakeholders