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Regulatory Submissions Manager, Osaka
Job Description
Job Title: Regulatory Submissions Manager
Location: Osaka, Japan
Overview
A global clinical research organisation is seeking an experienced Regulatory Submissions Manager to support clinical trial start-up and regulatory submission activities in Japan. This role sits within a well-established clinical operations team and plays a key part in ensuring regulatory readiness, submission quality, and smooth study initiation across global and local clinical programs.
The organisation supports Phase I–IV clinical development programs across multiple therapeutic areas and is known for its strong regulatory expertise, structured processes, and commitment to high-quality clinical execution.
Key Responsibilities
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Lead and execute regulatory start-up activities for global and local clinical studies, ensuring timelines and quality standards are met
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Perform quality control reviews of regulatory submission packages and site essential documents
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Prepare, review, and approve informed consent forms in line with regulatory and ethical requirements
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Review applicable regulations and guidelines to proactively identify and resolve start-up risks or challenges
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Contribute to bid defenses, client meetings, capability presentations, and regulatory or quality audits as required
Candidate Profile
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Bachelor’s degree or advanced degree (Master’s or PhD) in Life Sciences or a related discipline
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5+ years of experience in clinical research, ideally within a CRO or pharmaceutical environment
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Background may include experience as a CRA, Project Manager, or within regulatory start-up/submissions
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Strong understanding of regulatory submissions activities and clinical trial start-up processes
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Solid knowledge of ICH guidelines and applicable global and local regulatory requirements
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Demonstrated ability to organise, guide, and coordinate team activities across multiple projects
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Strong written and verbal communication skills
Language Requirements
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Native-level Japanese (JLPT N1)
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Business-level English proficiency (minimum TOEIC score of ~500 or equivalent)
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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