Senior Manager, Regulatory Affairs, Japan
BeOne Medicines · Japan
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:
The Associate Director, Regulatory Affairs, Japan will be responsible for developing, implementing, and advising on Japan regulatory strategies for development programs to secure and maintain market access for product(s) in line with Global and Japan business objectives, and in coordination with key internal stakeholders. This individual will manage regulatory aspects of compounds/biologics through all phases of development, post-approval, and life-cycle of the product. The incumbent will provide leadership and strategic regulatory oversight for designated projects ensuring that the latest requirements and standards are met. Externally, the individual will interface with outside regulatory agencies and business partners regarding development, regulatory, and registration strategies in Japan. He/she will also provide line management, people development, and performance management as well as support/lead development and implementation of department policies.
Essential Functions of the job:
Responsibilities
- Provides high level strategic and operational regulatory direction and mentorship on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval in Japan markets, regulatory strategic development plans and risk assessments, critical issue management and advice on Health Authority interactions in Japan.
- Uses extensive knowledge of Japan and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate goals.
- Responsible for the preparation and submission of documentation to support investigational and marketing registration packages in Japan and ensures timelines are met.
- Reviews sections of CTN, NDA, and other submission documents in support of clinical trials and marketing applications, and their amendments in Japan in conformance with Japan regulatory requirements.
- Liaises and negotiates with Japan regulatory authorities as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals of product and labeling changes.
- Maintains awareness of Japan and global regulatory environment and assesses impact of changes on business and product development programs. Facilitates policy and development of standard interpretation of Japan regulation.
- Integrates functional expertise with business knowledge to solve problems and makes good decisions for the overall business.
- Trains, develops, and manages direct reporting line.
- Manages critical issues, taking leadership for the regulatory contribution.
- Responsible for assisting with the development and implementation of regulatory processes.
- Recruits, develops, manages and mentors regulatory professionals and helps create a goal oriented culture.
Core Competencies, Knowledge and Skill Requirements
- Minimum 10 years of experience in the biotechnical or pharmaceutical industry, and a minimum of 5 years’ experience in a Regulatory capacity with a broad background.
- Minimum 5 years of experience working on development programs running in Japan as a Japan regulatory lead, and prior experience with both small molecules and biologics.
- Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends.
- Extensive regulatory experience with CTNs, NDAs/BLAs/MAAs, lifecycle management, interactions with Japan Health Authorities, leading and managing regulatory teams, developing and implementing regulatory strategies with a proven track record of significant regulatory accomplishments.
- Very strong strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges (e.g., new competition, shifting market environment) and the ability to balance short-term needs with long-term vision.
- Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism.
Communication & Interpersonal Skills
- Excellent interpersonal, oral and written communication skills in Japanese and English, especially regulatory documentation in Japanese with high quality and grammatical accuracy. Able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to be internal and external stakeholders.
- Skilled in conflict resolution/negotiation. Fosters open communication. Listens and facilitates discussion.
- Strong negotiating skills and ability to think creatively and develop creative solutions.
- Proven ability to build trust and respect within the organization.
- Ability to prioritize and handle multiple projects simultaneously.
- Interacts with BeiGene employees and senior management.
- Interacts with external business partners and Regulatory Agencies.
Qualification Required:
Computer Skills:
Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint)
Other Qualifications:
Travel:
Ability to work on a computer for extended periods of time
What We Offer To Our Valued Employees
Market competitive compensation package including performance-based annual bonus scheme
Company shares (generous welcome grant!)
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
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