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Regulatory Affairs Associate
Toranomon 40MT Builings, 7th Floor, 5-13-1 Toranomon, Minato-ku Tokyo, Tokyo N/a JP
Job Description
Job Title: Regulatory Affairs Associate
Location: Japan
Role Overview
A life sciences organisation is seeking a Regulatory Affairs Associate to provide hands-on administrative and documentation support to the Regulatory Affairs function in Japan. This role is well suited to a detail-oriented professional with strong bilingual documentation skills who is comfortable working with English and Japanese regulatory materials.
The position plays a key supporting role in regulatory project coordination, documentation quality, and submission readiness, working closely with senior regulatory leadership and cross-functional teams.
Key Responsibilities
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Provide day-to-day administrative and coordination support for regulatory projects, including responding to internal and external queries
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Format regulatory documents in both English and Japanese in line with established templates, style guides, and regulatory standards
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Support preparation, review, and quality control of XML files for regulatory submissions
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Assist with document uploads and submissions via the PMDA Gateway in accordance with internal procedures and regulatory requirements
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Prepare, maintain, and archive regulatory contact reports to ensure accurate documentation and traceability of communications
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Draft clear and accurate meeting minutes in both English and Japanese, capturing key discussions, decisions, and action items
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Maintain organised records of regulatory documentation and correspondence with health authorities
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Perform quality checks on regulatory documents, ensuring grammatical accuracy, consistency, and uniform formatting across English and Japanese materials
Candidate Profile
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Strong English reading, writing, and comprehension skills (basic spoken communication acceptable)
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Native-level or highly proficient Japanese
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Advanced Microsoft Word formatting capabilities
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Experience performing quality control (QC) of bilingual (English/Japanese) documentation
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Ability to review, refine, and improve machine-translated regulatory texts
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High attention to detail with strong organisational and critical-thinking skills
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Comfortable managing multiple tasks and working across functions in a regulated environment
Reporting & Collaboration
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Reports directly to senior Regulatory Affairs leadership in Japan
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Regular interaction with cross-functional teams to support interconnected regulatory and operational projects
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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