Work Location , Expected Annual Income :
Tokyo,7.0M ～ 11.0M
About the Company :
Global Oncology Diagnostics Company
Responsibilities :
Position Summary
Essential Duties and Responsibilities:
- Responsible for managing and developing regulatory strategies and project workflow including adhering to project timelines and prioritizing deliverables.
- Responsible for creating and delivering documentation and implement effective submission domestically.
- Lead the submission/approval strategy and execute the project in light of PMDA requirements, business needs, reimbursement strategy, system development, etc. together with the relevant teams.
- Execute assessment of product changes to capture any impact to existing or in-process product registrations and letters to file and develop strategies.
- Collaborate and document regulatory activities for clinical studies as needed.
- Responsible in submission activities for new product approvals and maintenance of on- market products, and include lead for pre-submissions, premarket approvals (PMAs), conformity assessments of QMS and reliability submission etc.
- Collaborate closely with affected functions and in project team to ensure alignment of regulatory strategy and input on risk and benefit of potential plans.
- Lead communication with PMDA/MHLW to effectively bring submission/approval within expected timeline.
- Identify risk area, safety issues and potential solutions through planning projects and existing products.
- Strong collaborate cross-functionally and communicate regulatory requirements to project teams.
- Manage in implementing department procedures and regulatory compliance processes.
- Acquire and share current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and discipline as relevant to assigned projects.
- Effectively strong communicate updates on assigned projects and changes in regulatory landscape to team members and leader.
- Support QA processes and activities
Benefits :
Employment Type: Full time employee (正社員)
Office Location: Central Tokyo, Japan
Working Model: Hybrid, 2-3 days in office with flex time.
Interviews: 3
Budget: Up to 11 Mil (base+bonus)
Welfare and Insurances: Covered
Required Experience / Abilities / Skills :
Qualifications:
- Bachelor’s degree, or higher in biochemistry, life-sciences, engineering, public health, or equivalent
- +5 years of experience of regulatory affairs or clinical research. Preferably 3 years of experience in such as SaMD, IVD, genetic testing, precision medicine, and oncology.
- Familiar with regulatory issues and challenges preferably associated with IVD, CGP, CDx and medical device development.
- Knowledgeable in the aspects of regulatory strategy creation, design control, QMS.
- Experience providing and leading RA feedback to cross-functional project teams, active and successful regulatory guidance, and RA strategies.
- Experience of leading and maintaining product approvals and change control.
- General understanding of genomic/molecular technologies and the impact on outcomes and diagnostic results.
- Professional skill of negotiation to PMDA/MHLW to effectively bring submission/approval within expected timeline.
- Strong organizational skills, excellent oral and written communication skills in both Japanese and English.
- Attention to details, ability to compile data, summarize results and handle multiple tasks to prioritize and schedule work to meet business needs.
- Demonstrated ability to meet timelines, and work across varied functions, cultures, and backgrounds.