RA Manager

About the company

Join a healthcare organisation working in a highly regulated, quality-focused environment. Its work depends on bringing products to market responsibly and ensuring that regulatory requirements are met throughout their lifecycle. This creates an opportunity to contribute to work that supports both business priorities and the needs of customers and patients.

The organisation offers a collaborative setting where sound judgement, attention to detail and effective partnership across teams are valued. As a permanent member of the Tokyo-based team, you will have the opportunity to develop regulatory processes and contribute your expertise to a business operating in a complex, evolving sector.

What the job entails

As Regulatory Affairs Manager, you will help ensure that the organisation’s activities and products meet applicable regulatory requirements in Japan. You will guide regulatory strategy and provide clear, practical advice to colleagues, helping teams understand their obligations and make informed decisions.

The role involves coordinating regulatory submissions and documentation, monitoring changes to relevant requirements, and supporting communication with regulatory authorities. You will work across functions to align regulatory plans with business needs, address issues as they arise and maintain accurate, inspection-ready records. You will also contribute to improving regulatory processes and building awareness of regulatory responsibilities across the organisation. This is an opportunity to take ownership of a critical function and bring a considered, collaborative approach to regulatory decision-making.

Key requirements

• Experience in regulatory affairs within a regulated industry, such as healthcare, pharmaceuticals or medical devices.
• Working knowledge of Japanese regulatory requirements and the processes involved in submissions and product lifecycle management.
• Ability to interpret regulatory guidance and translate it into clear, actionable advice for colleagues.
• Experience preparing, reviewing or coordinating regulatory submissions and supporting documentation.
• Strong written and verbal communication skills, with the ability to work effectively across functions and with external stakeholders.
• A high level of accuracy and organisation, with the judgement to manage competing priorities and sensitive information.
• Confidence monitoring regulatory developments and assessing their potential impact on business activities.
• A collaborative, proactive approach, with a commitment to quality, compliance and continuous improvement.
• Professional proficiency in Japanese and English to support regulatory work and cross-functional communication.