Job Description

Summary
The RA Manager will play a crucial role in supporting business growth in Japan from a regulatory affairs perspective. This position requires close collaboration with QA and Marketing to establish a seamless transition process while taking ownership of future portfolio strategy.

Key Responsibilities
• Develop and implement best-in-class submission strategies.
• Assess the acceptability of quality, preclinical, and clinical documentation for submission filing.
• Lead interactions and negotiations with PMDA and MHLW to ensure timely submission approvals.
• Build and maintain positive relationships with regulatory authorities.
• Monitor regulatory changes and assess their impact on submission strategies, updating internal stakeholders accordingly.
• Prepare and submit required regulatory reports and responses.
• Provide regulatory input and follow-up for inspections and audits.
• Support regulatory aspects of product recalls and related communications.
• Review and assess external regulatory documents and communications.
• Advise internal stakeholders on regulatory issues and requirements.
• Provide training on regulatory compliance, including safety-related operations.
• Represent the company in industry meetings and regulatory discussions as needed.

Experience
• Extensive knowledge and experience with Japan’s regulatory landscape.
• Expertise in developing Japan regulatory strategies and executing high-quality submissions for medical device registrations.
• Established relationships with PMDA and MHLW.
• Hands-on experience with regulatory submissions.
• Strong collaboration with regional and global teams.
• Experience working cross-functionally with Sales, Marketing, QA, R&D, and other key departments.
• Strong strategic thinking and business planning mindset.
• Experience with regulatory submissions and direct communication with PMDA.
• Prior experience with Class 3 or higher medical devices is preferred.

Education
• Bachelor’s degree in pharmacy, biomedical sciences, or a technical discipline (e.g., biology, chemistry, engineering).
• Advanced degree preferred.
• Required qualification of safety controller.

Skills & Competencies
• Proficiency in both English and Japanese.
• Strong communication and stakeholder management skills.
• Adaptability and enthusiasm for working in a start-up environment.
• Ability to navigate challenges and unprecedented issues proactively.
• Collaborative mindset with the ability to manage conflicting interests.
• Attention to detail and commitment to compliance.

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