Tokyo, Japan
Published on: November 13, 2026
EuroAPI is a pharmaceutical company with expertise in active ingredient production and contract development and manufacturing organisation (CDMO) activities. EuroAPI Japan G.K. works within this international business, connecting Japanese regulatory requirements with the company’s wider Sales and QARA teams and manufacturing sites.
This role offers the opportunity to contribute to the compliant supply of human and animal health products in Japan. You will work across regulatory affairs, quality and manufacturing, while supporting customer registrations and CDMO activities. The position combines local regulatory responsibility with collaboration across the wider organisation, offering a broad view of how regulatory decisions support products, customers and manufacturing operations.
As Regulatory Affairs Manager, you will lead regulatory activities for EuroAPI in Japan, ensuring that registrations, manufacturing accreditations and ongoing compliance meet local requirements. You will prepare and submit dossiers to Japanese Health Authorities, maintain Japan Master Files and Foreign Manufacturer Accreditations, track approvals and respond to regulatory enquiries. You will also advise customers on information for their registrations and provide regulatory support to manufacturing sites and CDMO activities.
Alongside registration work, you will support Japan’s GMP organisation, maintaining relevant procedures, training programmes and Product Quality Reviews, and overseeing the archiving of GxP and sales-related documents. You will manage Japan-related change control, monitor regulatory developments and share updates with QARA Corporate. Representing EuroAPI in the Pharmaceutical Manufacturers’ Association of Tokyo, you will help support compliance with the Japanese Pharmacopeia.
As part of our hiring process, this role may use Keystone AI’s artificial intelligence or automated tools to assist with reviewing and screening applications. These tools support, but do not replace, human judgment in making hiring decisions.
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CGP Group is an affirmative equal-opportunity employer and recruitment firm. We evaluate qualified applicants without regard to race, color, religion, creed, gender, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability, or any other protected class. Information provided in this advertisement is for recruitment purposes only.