- Location
- Japan
- Type
- Full-time
- Seniority
- Director
- Education
- Master
- Source
- Workday
Description
About us
BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn and X (formerly known as Twitter).
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
Job Description:
General Description:
- Local Representative for Regulatory Affairs, Local Compliance
- Provide leadership and strategic direction for Regulatory Affairs and Compliance Communication in Japan, primarily in the post-marketing phase, with proactive input into commercial regulatory requirements during development.
- Act as an internal consultant on pharmaceutical regulations, including the PMD Act.
- Collect, analyze, and implement domestic pharmaceutical regulations; monitor and share regulatory trends (e.g., ICH, PIC/S, MHLW/PMDA).
- Promote regulatory awareness through internal briefings and materials on PMDA/MHLW updates and guidelines.
- Establish and maintain regulatory compliance systems, including SOPs, internal audits, and governance support.
- Oversee business license management (e.g., MAH, manufacturer) and collaborate with GQP/GVP departments.
- Package Insert (labeling) maintenance for commercial products
- Support the Three Key Roles under the PMD Act (General Marketing, Safety, and Quality Compliance Officers).
- Lead and prepare for inspections by regulatory authorities, including the Tokyo Metropolitan Government.
- Manage GMP inspections (pre-approval, periodic) and foreign manufacturer accreditation with CMC Regulatory and Quality.
- Handle PMDA/MHLW interactions for commercial products, including consultations, inquiries, and GMP/CMC variation responses.
- Lead and coordinate CMC variation submissions with global and local CMC Regulatory teams.
- Collaborate with global regulatory counterparts to align regional and global strategies.
- Coordinate with internal teams (e.g., Development, QA, Safety, Manufacturing, Marketing, Medical Affairs) and external stakeholders (e.g., industry associations, academic societies).
- Support Japan-specific regulatory requirements such as RMPs, re-examination applications, and post-marketing surveillance.
- Maintain package inserts and review promotional materials for regulatory compliance.
Qualification Required:
Education Required:
Bachelor degree and/or Master Degree in Pharmacy or life science.
Other Qualifications:
- Ability to work independently and effectively handle multiple priorities in a fast-paced environment
- Excellent interpersonal skills, strong organizational skills and effective written and verbal communication skills across all levels within an organization
- Scientific background
Computer Skills:
- Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook
Travel: up to 10%
What We Offer To Our Valued Employees
- Market competitive compensation package including performance-based annual bonus scheme
- Company shares (generous welcome grant and performance-based annual equity plan!)
- In-house and external learning and development opportunities
- Fantastic benefits program and keep improving!
- Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we.
- Join us and Make momentum in your career!
BeOne Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
BeOne is committed to respect and protect personal information rights of job applicants and will process job applicants’ personal information in accordance with applicable laws and regulations.
Due to BeOne’s global operation, job applicants’ data will be stored overseas with adequate protection. Besides, job applicants’ data will be stored for no longer than is necessary to facilitate potential application for other suitable positions in BeOne. For further details, please refer to BeOne’s Job Applicant Privacy Policy (https://beonemedicines.com/privacy-policy).
If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms. If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms.
If you have any concern, please DO NOT provide any resume or other personal information to us.