MAH Regulatory Affairs Expert (Market Authorization) - Remote, Japan
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AI Summary
Roles and Responsibilities
Act as the General Marketing Supervisor (GMS), overseeing Quality Assurance and Pharmacovigilance functions and reporting to the legal representative. Manage both pre- and post-approval GMS responsibilities with effectiveness and accountability.
Develop and implement regulatory strategies for assigned pharmaceutical products, executing activities independently in compliance with Japanese regulations, guidance, and established procedures.
Lead the preparation and submission of regulatory documentation, including Module 1 and Application Forms for Marketing (AFM), provide regulatory intelligence, liaise with local health authorities (PMDA and MHLW), support NHI price listing, and define overall regulatory strategies.
Typical Accountabilities
Serve as GMS for assigned products, with full accountability for achieving regulatory milestones across the entire product lifecycle and for all categories of medicinal products.
Apply in-depth regulatory expertise to support approvals and ensure uninterrupted product supply, proactively identifying regulatory risks and developing appropriate mitigation strategies.
Requirements
- Extensive experience in regulatory affairs, with the ability to evaluate complex scientific critically and technical data to assess regulatory suitability and ensure clear, well-supported regulatory justifications.
- Strong written and verbal communication skills, with the ability to convey issues clearly, concisely, and logically; excellent listening and stakeholder engagement capabilities.
- Broad understanding of related disciplines such as pharmaceutical manufacturing, pharmacovigilance, and quality assurance, combined with a creative and solution-oriented approach to problem solving.
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