About This Role
This role involves supporting a global life sciences consulting company's Japan team as a Regulatory Affairs professional. It offers exposure to international clients and ownership of Japanese regulatory submissions and projects within the pharmaceutical and medical device sectors.
Responsibilities
- Prepare, submit and maintain Japanese Master Files (MF/J-DMF) for foreign API manufacturers
- Translate and adapt English Drug Master Files into Japanese, ensuring accurate content and appropriate formatting
- Coordinate with PMDA and Marketing Authorization Holders (MAHs) on submissions, regulatory queries and lifecycle maintenance
- Manage foreign manufacturer registration and site accreditation activities
- Compile and update regulatory dossiers, ensuring submission quality and compliance with Japanese requirements
- Provide regulatory advice and updates on Japanese regulations to international clients
- Manage regulatory projects, including timelines, resources, budgets and client communication
- Support the development of new regulatory services in Japan
Requirements
- 5+ years of Regulatory Affairs experience in Japan, preferably in API registration or ICC services
- Strong understanding of Japanese pharmaceutical regulations and guidance
- Hands-on experience with Japanese Master File preparation, submission and maintenance
- Experience liaising with PMDA and MAHs
- Native-level Japanese and strong English proficiency, including regulatory writing and bilingual communication
- Previous project management experience
- Strong attention to detail, stakeholder management and client communication skills
Nice to have:
- GMP auditing
- Familiarity with EU and/or US registration processes
- Experience supporting foreign pharmaceutical or API manufacturers entering the Japanese market
Benefits
- Global exposure: Work with international pharmaceutical clients and colleagues across a multinational life sciences consultancy
- Meaningful ownership: Manage Japanese regulatory submissions and support products throughout their lifecycle
- Specialist scope: Apply and deepen your expertise in API registration, Japanese Master Files and ICC services
- Varied responsibilities: Combine regulatory work with client advisory, project management and business development support
- Cross-border impact: Help overseas manufacturers navigate Japanese regulatory requirements and access the Japanese market
About the Company
Our client provides regulatory, quality and compliance services to pharmaceutical and medical device companies worldwide.