Benefits

• Attractive salary package with performance bonus
• Flexible working model to support a balanced lifestyle
• High-visibility role working directly with Japan Country Head
• Ongoing opportunities for career progression into formal team leadership

About the Company
Join a market-leading global Contract Research Organisation (CRO) partnering with biotechnology and pharmaceutical companies to deliver high-quality clinical trials worldwide. With a strong international footprint and continued investment across APAC, the organisation is expanding its direct regulatory capability in Japan. The Japan business represents a key strategic growth market, supported by global infrastructure and leadership. This is an opportunity to join a high-performing CRO environment where regulatory expertise is central to operational excellence and client delivery.

About the Opportunity
The Senior Manager, Regulatory Affairs Operations will oversee regulatory deliverables across clinical trials within Japan, ensuring full compliance with ICH-GCP guidelines and local regulatory requirements. Reporting directly to the Japan Country Head, you will provide operational regulatory leadership while working closely with Project Management and Clinical Operations teams. You will be responsible for managing regulatory submissions, documentation, and start-up activities to ensure timely approvals and high-quality execution.

Duties

• Lead and manage regulatory submission deliverables (RA and EC) to ensure timely clinical trial approvals
• Review and approve regulatory documentation to ensure compliance with ICH-GCP and local regulations
• Act as key liaison with regulatory authorities and ethics committees as required
• Contribute to process optimisation and continuous improvement initiatives within regulatory operations
• Support bid preparation and provide regulatory input into business development activities
• Collaborate with global stakeholders to ensure alignment with international standards and delivery models

Skills and Experience

• Current or prior CRO regulatory experience is essential
• Strong knowledge of Japan regulatory requirements and clinical trial start-up processes
• Minimum two years’ line management experience is essential, or demonstrated readiness to step into formal team leadership
• At least 5 years’ experience within the pharmaceutical or clinical research industry
• Fluent Japanese (native-level proficiency) and business-level English communication skills are required

Culture
Join a collaborative, quality-focused, and commercially aware organisation with strong global backing. The Japan operation is in an exciting growth phase, offering high visibility, direct leadership engagement, and the opportunity to shape regulatory capability locally while contributing to global standards of excellence.

How to Apply
Click apply or contact Rohan Lallbeeharry – Senior Recruitment Consultant – at rlallbeeharry@hpgconnect.com or call +61 485 860 660 for a confidential discussion.

About Healthcare Professionals Group

Healthcare Professionals Group recruits all positions:

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.