Job description
Accurate and in-depth understanding of regulations governing the application, approval, and maintenance of ethical pharmaceuticals, OTC products, and regenerative medical products in Japan. Practical experience reviewing QA-related submission documents, evaluating change controls, managing batch release of commercial products, overseeing QMS and SOPs, conducting vendor audits, and handling market complaints.
Working knowledge of regulatory requirements for maintaining Type I, Type II, or regenerative medical product Marketing Business Licenses. Demonstrated responsibility for GQP (Good Quality Practice) activities, including review of manufacturing documentation, deviation management, change control, and CAPA, in compliance with Japanese regulations.
Requirements
Strong scientific background with the ability to prepare pharmaceutical documentation for submission to Japanese regulatory authorities (PMDA and MHLW). Proficiency in reviewing English-language documents and correspondence from global clients and providing timely, accurate written responses in English. Ability to clearly communicate and explain Japanese regulatory requirements to overseas clients and stakeholders.
\ Experience preparing meeting materials using presentation tools (e.g., PowerPoint) and delivering presentations in English. Hands-on experience conducting GMP audits of manufacturing sites. Experience supporting GMP inspections conducted by PMDA or other regulatory authorities in Japan; prior experience with PMDA-led inspections is preferred.
Minimum of three years’ experience as a Quality Assurance Manager or Quality Control Manager supporting Type I, Type II, or regenerative medical products under a Marketing Business License; experience in a pharmaceutical company or CRO is preferred.