MAH Regulatory Affairs Expert (Market Authorization) - Remote, Japan

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.