Why this seat is different in Japan
The hire may be a licence condition. A marketing authorisation holder (製造販売業者) under the Pharmaceuticals and Medical Devices Act (薬機法) must appoint three named officers: the general marketing compliance officer (総括製造販売責任者), the quality assurance officer (品質保証責任者) and the safety management officer (安全管理責任者). Each has qualification and experience requirements set in the regulations, and the names are registered with the authorities. If this role carries one of those designations, the JD must say which, and the candidate must meet the statutory requirement before anything else.
The regulator negotiates in Japanese and in person. Approval and certification strategy, consultations with the Pharmaceuticals and Medical Devices Agency (PMDA), inspection responses and the Japanese quality-management-system ordinance (QMS省令) all run in Japanese. Global dossiers must be adapted, not translated, and the timing of Japanese approval often decides the launch calendar for the whole region.
Two candidate pools rarely overlap. Contract research and regulatory service organisations produce regulatory affairs leaders with strong submission experience and a business-development reflex; manufacturers produce quality leaders with deep system and inspection experience. A head of QA and RA combined needs both and the pool is correspondingly small.
Purpose of the role
Lead quality and regulatory affairs for the Japan entity: secure and maintain approvals and licences, run a quality system that passes inspection, manage post-market safety, and give the business a regulatory strategy that supports launches and growth within the law.
Key responsibilities
Regulatory affairs
- Set regulatory strategy for the Japan portfolio and lead submissions for approval, certification and notification.
- Manage consultations, inquiries and inspections with the PMDA, the ministry and prefectural authorities.
- Maintain licences and registrations, including foreign manufacturer registration where relevant.
Quality management
- Own the quality management system under the QMS ordinance and group standards, including document control, change control, deviations and corrective action.
- Lead internal and external audits, supplier and distributor quality, and the licensed-site compliance programme.
Post-market safety
- Run adverse-event reporting, recalls and field actions under the safety-management ordinance with the named safety officer.
Business partnership
- Give commercial and launch teams a clear regulatory timeline and the constraints on claims and promotion.
- Review promotional materials for compliance with the Act.
Team and interface
- Lead and develop the QA/RA team, and report to regional and global functions in English.
Candidate profile
Must have
- Ten or more years in regulatory affairs or quality assurance in the Japanese pharmaceutical, device or diagnostics industry, with at least four leading a team.
- Direct experience of PMDA consultation and submissions, and of a regulatory or quality inspection.
- The statutory qualifications for any named-officer role attached to the seat.
- Working knowledge of the QMS ordinance, GVP and the licensing framework.
Preferred
- Both regulatory and quality leadership in one career.
- Launch of a new product class or a first-in-Japan approval.
- Experience at both a manufacturer and a service provider.
Language
- Japanese at native level for regulators, submissions and the team.
- English at business level for global regulatory and quality functions, dossiers and reporting.
Decide before you post
- Which named-officer designations, if any, the role holds, and the statutory requirements that follow.
- Regulatory affairs, quality assurance, or both.
- Licence type and site classification.
- The launch and submission calendar for the next 24 months.
- Any open inspection findings. Candidates will find out.
How hard is this hire
Hard. In a recent search for a Regulatory Affairs Director in clinical services we approached more than 80 professionals. The named-officer requirements remove candidates who are otherwise strong, and the combined QA/RA profile is rarer still. Expect four to six months. Searches fail when the JD omits the named-officer requirement and the finalist cannot be registered.
Interview questions that separate candidates
- Walk me through a PMDA consultation you led. What did you ask for, what did you get, and what did it do to the timeline?
- Tell me about an inspection finding and the corrective action you ran.
- Which named-officer roles have you held and under which licence?
- How do you adapt a global dossier for Japan rather than translate it?
- Describe a recall or field action you managed.
