Regulatory Affairs Specialist

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募集要項

会社概要

同社は世界最大級の外資系医療機器メーカーで、世界中に40,000人を超える従業員を抱えるグローバル企業です。「切らない医療」に特化した医療機器を提供しており、臨床開発や薬事申請なども事業の一環として積極的に行っています。そのような取り組みにより、医療の進化に貢献し、患者さんの健康や医療の向上に寄与しています。

業務内容

Main responsibilities:

• Ensures rapid and timely approvals for respective product lines by plans on all product registration, manage all product registrations' preparation and documentation.
• Interacts with regulatory agency personnel in order to expedite approval of pending registration and answers any questions on product documentation.
• Provide management team with regular updates on product registration and new regulations from government body.
• Provides input on regulatory- related issues associated with compliance and achieving the business plans.
• Prioritize and plan on product registration for his/her respective product lines.
• Preparing, coordinating and submitting regulatory applications to the local health authority.
• Maintain an active knowledge of the status of pending approvals and shepherd registrations through the approval process.
• Provide the management team with regular updates on product registration.
• Ensure product registrations are reviewed and renewed as required.
• Establish and implement plans to maintain a trusted relationship with the local health authorities through regular meetings, discussions, training and education.
• Lobby the local health authorities using constructive/scientific challenges to regulations. This should include guidance on alternative solutions to country regulatory needs.
• Supports tender operations by timely supply of accurate regulatory documents.
• Establishes relationships with local medical device industry groups and works with industry peers to lobby the Competent Authorities in matters of regulatory issues and to influence local policies.
• Establish and maintain a good working relationship with regional RA peers to gain positive & timely support for document preparation.
• Serves as regulatory consultant to marketing team and government regulatory agencies.
• Complete the mandatory Quality training subject to the defined timeline.
• And ensure compliance with internal Quality system and policy.

応募条件

Minimum requirements:

• Have experience in any of the following
  • Clinical development, R&D or QA experience in the healthcare industry
  • Any job in the medical device industry
  • Regulatory positions in industries other than healthcare (e.g. consumer goods, cosmetics, etc.)
• Able to proactively think, plan and negotiate without adhering to existing strategies and processes
• There is agility to start working even if all the information is not available
• Interpret change positively and move forward
• Possess a business sense that adapts to changing situations
• English skills
  • Business level reading and writing skills (Must be able to handle telephone calls and meetings)

Preferred qualifications:

• Pharmaceutical affairs application experience 5 years or more (less than manager)
• Can independently manage difficult negotiations with business divisions, PMDA, and global
• English skills
  • For potential recruitment, those who are still studying are also welcome.

給与

700 - 1000 万円

勤務地

東京