RA Manager

勤務地 東京都
業界・業種 医療・製薬
契約タイプ Permanent
給料 Negotiatable
参照番号 47769

【COMPANY OVERVIEW】

American company specializing in diabetes care

【JOB RESPONSIBILITIES】

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.

 

【REQUIREMENTS】

  • Bachelor’s degree in pharmacy, biomedical sciences, or a technical discipline (e.g., biology, chemistry, engineering).

  • Advanced degree preferred.

  • Required qualification of safety controller.

【WELCOME SKILLS AND 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.

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.