Join a global precision oncology leader as a Senior Specialist in Regulatory Affairs, overseeing strategy and execution to bring innovative cancer diagnostics to the Japanese market. Lead PMDA engagements, manage cross-functional alignment, and play a key role in enabling life-saving solutions for patients through regulatory excellence.
Key Responsibilities
- Lead and mentor the regulatory team to drive timely project execution
- Manage full-cycle preparation, submission, and approval of regulatory documents
- Serve as primary liaison with PMDA/MHLW to achieve successful approvals
- Assess product changes and determine regulatory implications
- Collaborate across functions to align strategy and mitigate regulatory risk
- Ensure compliance with evolving Japanese IVD/device regulations
- Support clinical study regulatory planning and execution
Required Skills and Qualifications
Experience:
- Bachelor's degree in Life Sciences or related field
- 8+ years in regulatory affairs, with 3+ years in IVD or oncology
Technical Skills:
- Deep knowledge of Japan's medical device and IVD regulatory environment
- Experience with design controls, QMS, and PMDA negotiations
Soft Skills:
- Proven team leadership and project prioritization
- Strong collaboration and communication skills
Language Requirements
- Japanese: Native
- English: Business level
Preferred Skills & Qualifications
- Background in genomic or molecular diagnostics
- Ability to manage complex submissions and global alignment
About the Company
Our client is a US-headquartered global leader in precision oncology, focused on transforming cancer care through proprietary blood tests and advanced analytics. The company enables early detection and treatment personalization, improving outcomes for patients worldwide.
Why You'll Love Working Here
- Lead the regulatory vision for Japan with full strategic ownership
- Collaborate closely with health authorities and cross-functional teams
- Drive access to life-saving diagnostics in a fast-growing field
- Enjoy flexible work arrangements and a mission-driven environment
- Be part of a top-tier biotech organization with global impact
Don't Miss Out - Apply Now!
