Benefits
• Senior leadership opportunity in a Japan market build phase
• Strategic influence on regulatory positioning in Japan
• Competitive base salary with bonus structure
• Flexible working arrangement, remote initially
• Opportunity to shape and build a future team

About the Company
Our client is a global clinical research organisation supporting biotechnology and pharmaceutical companies with the design and delivery of clinical trials across multiple regions. With established operations internationally, the organisation is now strengthening its direct presence in Japan as part of its continued global expansion.

About the Opportunity
This is a senior regulatory leadership role responsible for establishing and overseeing regulatory operations capability within Japan. Reporting directly to the Japan Country Head, the Associate Director will provide strategic regulatory oversight across ongoing and future clinical trials.

The role will focus on regulatory deliverables within Japan, ensuring compliance with PMDA and local requirements while supporting business growth initiatives. The successful candidate will act as a senior regulatory advisor to internal stakeholders and clients, contributing to feasibility assessments, bid defence activities and strategic planning.

Initially this role will operate as an individual contributor, with the expectation of building and leading a regulatory team as Japan operations expand.  This is a pivotal appointment in strengthening the organisation’s long-term presence in Japan.

Duties

• Provide strategic oversight of regulatory operations in Japan
• Oversee preparation and review of regulatory submissions
• Act as Japan regulatory subject matter expert
• Advise internal teams on regulatory strategy and timelines
• Support business development and bid defence activities
• Build scalable regulatory processes and frameworks
• Collaborate closely with global clinical and project teams
• Represent regulatory function in leadership discussions

Skills and Experience

• CRO regulatory operations background
• Strategic and commercial regulatory capabilities
• PMDA submission expertise
• Leadership experience
• Fluent Japanese and English
• Life sciences degree

Culture
Fast-paced, growth-oriented and collaborative. A build-phase environment where senior leaders work closely together to shape the future direction of the Japan business.

How to Apply
Click apply or contact Adrian McConchie, Director Executive Search at amcconchie@hpgconnect.com in confidence.

About Healthcare Professionals Group
Healthcare Professionals Group recruits all positions: executive, permanent, contracting/temp, at all levels, across all areas of healthcare - Pharmaceuticals, Biotechnology, Medical Technology and Clinical Care.
• Medical Affairs & Life Sciences Recruitment - Clinical Research, Market Access, Medical Affairs, Pharmacovigilance, Quality, Data Management, Regulatory Affairs, Scientific;
• Commercial Recruitment - Marketing, Sales, Analytics, Government and External Affairs;
• Business Operations & Infrastructure Recruitment - Administration, Customer Service, Engineering, Finance, Human Resources, IT, L&D, Legal, Manufacturing, Operations, Supply Chain, Warehouse;
• Clinical Care Recruitment - Allied Health, Aged Care, General Practice, Medical Imaging, Medical Management, Medical Specialties, Nursing.

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