Regulatory Submissions Manager, Osaka

Osaka, Osaka N/a

Posted: 01/29/2026 Employment Type: Direct Hire/Perm Job Category: Clinical Development and Operations Job Number: 625260 Is job remote?: No Country: Japan

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

  • Lead and execute regulatory start-up activities for global and local clinical studies, ensuring timelines and quality standards are met

  • Perform quality control reviews of regulatory submission packages and site essential documents

  • Prepare, review, and approve informed consent forms in line with regulatory and ethical requirements

  • Review applicable regulations and guidelines to proactively identify and resolve start-up risks or challenges

  • Contribute to bid defenses, client meetings, capability presentations, and regulatory or quality audits as required

Candidate Profile

  • Bachelor’s degree or advanced degree (Master’s or PhD) in Life Sciences or a related discipline

  • 5+ years of experience in clinical research, ideally within a CRO or pharmaceutical environment

  • Background may include experience as a CRA, Project Manager, or within regulatory start-up/submissions

  • Strong understanding of regulatory submissions activities and clinical trial start-up processes

  • Solid knowledge of ICH guidelines and applicable global and local regulatory requirements

  • Demonstrated ability to organise, guide, and coordinate team activities across multiple projects

  • Strong written and verbal communication skills

Language Requirements

  • Native-level Japanese (JLPT N1)

  • Business-level English proficiency (minimum TOEIC score of ~500 or equivalent)
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