About us
BeiGene 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 BeiGene, please visit www.beigene.com and follow us on LinkedIn and X (formerly known as Twitter).
BeiGene 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:
About the Company:BeiGene (NASDAQ: BGNE; HKEX: 06160; SHA: 688235) is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. With a broad portfolio of more than 40 clinical trial candidates, we are committed to expediting the development of our diverse pipeline of novel therapies through collaborations or our own internal capabilities, with the aspirational goal of radically improving access to medicines for billions more people by 2030. BeiGene is a headquarter-less company by design, with a growing global team of approximately 8,000 colleagues across five continents.
General 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
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 and performance-based annual equity plan!)
Full-time working from home
In-house and external learning and development opportunities
Fantastic benefits program as per the current policy including;
Health Insurance provided
Medical Check-up, flu vaccine reimbursement
Home-office setup allowance
Monthly reimbursement for home office expenses (i.e. internet, mobile..)
Wellness benefits (Employee Assistance Program)
Paid parental leave
Annual leave
Marriage leave and allowance, condolence leave and allowance
And more as the benefit programs keep improving!
Plus you get to work with a dynamic team of collaborative, supportive, diverse, and fun professionals whose mission is clear: Cancer has no borders and neither do we.
BeiGene is proud to be an Equal Opportunity Employer:
We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
What We Offer To Our Valued Employees
Market competitive compensation package including performance-based annual bonus schemeCompany shares (generous welcome grant and performance-based annual equity plan!)In-house and external learning and development opportunitiesFantastic 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!BeiGene 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 TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with ClarityBeiGene 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 BeiGene’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 BeiGene. For further details, please refer to BeiGene’s Job Applicant Privacy Policy (https://www.beigene.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) BeiGene’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) BeiGene’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.