Senior Manager, Submission Operations Management

BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. There may be instances where “BeiGene” or “BeOne” are used to describe the company during this transition period.

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.beigene.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:

The Senior Manager of Submissions Operations (JP) will help establish the Submission Operations Team in Japan.  This role supports Regulatory Affairs personnel in the coordination, preparation, and submission of all Japanese CTNs/NDAs and lifecycle management of these submissions in electronic format to global Health Authorities, with immediate focus on supporting submissions in Japan, but also provide support as needed for China, APAC, EMEA, and NALA regions.  This role will also work cross-functionally and closely with GTS and Global Regulatory Operations Strategy & Innovation teams including but not limited to Regulatory Technology & Regulatory Information Management group to provide post-production support and training for colleagues in Japan, as needed.

Essential Functions of the job:

• Maintain working knowledge of regulatory guidance and regulations of ICH and regional/country Health Authorities, with a focus in Japan eCTD guidance.
• Lead and promote initiatives in moving the company forward with the implementation of new systems, processes and services.
• Assist and/or provide training to others on software tools and educate authors on publishing policies and procedures.
• Deliver a service to our customers, through the planning, production, distribution and archiving of submissions throughout the various geographical regions.  
• Lead strategic processes and provide strategic value to the overall positioning of the department with BeiGene
• Allocate project resources within the company and with offsite vendors to ensure adequate resourcing for BeiGene regulatory dossiers
• Responsible for forward planning of publishing resources with an awareness of long-term filing plans and advises senior management of resource implications.
• Interacts frequently with other functional areas. Maintains constructive and positive interactions with colleagues.
• Manages multiple projects. Maintains oversight of the status of multiple projects managed by junior colleagues. Participates in cross-functional projects.
• Discusses the status of ongoing projects with the team, sets expectations where necessary and reports on project statuses to senior management.
• Able to eloquently describe complex issues and recommend a resolution or workaround to senior management with appropriate consideration of possible impacts.
• Represent Regulatory Operations by taking the lead in submission planning meetings to help become familiar with the submission priorities.
• Lead the development and management of projects as applicable in support of the Regulatory Operations department.
• Manage/mentor and develop junior members of staff, as needed

Supervisory Responsibilities:  

• Mentor/train resources

Qualification Required:

Education Required:

BA/BS degree in Life Sciences with 10+ years of experience or MS with 8+ years of experience in Regulatory Operations within the biotechnology or pharmaceutical industry.  Proficient in written and spoken Japanese with experience in managing Japan submissions

Qualifications:

• Significant experience within a Regulatory Publishing environment including hands on eCTD experience and broad industry standard systems knowledge.
• Knowledge/experience with regulatory requirements for other regions is desirable.
• Management experience is preferred.
• Working knowledge of Japan local guidelines and ICH regulatory guidance and regulations.
• Understanding of PMDA structure and function.
• Strategic and criticalthinking is required, with a focus on process improvement and optimization.
• Excellent verbal, written skills, extensive organizational and time management skills and a strong attention to detail.
• Demonstrated ability to balance multiple tasks to achieve goals and to meet deadlines and customers’ expectations.
• Relevant experience includes project coordination/management, project management systems, electronic document management systems, global regulatory submissions or other experience directly related to project management and Regulatory Operations.
• Familiarity with pharmaceutical development and global Regulatory submissions is required.
• Detail-oriented, a self-starter, and comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment.
• Ability to communicate technical issues to a non-technical audience.
• Experience working in and directing cross-functional teams is highly preferred.

Computer Skills:   

• Working knowledge of business software, including MS Word, Excel, PowerPoint, Project, Adobe Acrobat and Outlook.
• Experience in the preparation and submission of documents using regulatory/document management systems/software (e.g. VAULT®, Documentum®, FirstDocs®, Publishing Tools, DXC Toolbox, Validation tools, etc) is required
• Veeva Vault Publishing experience preferred
• Veeva Valut RIM experience required

Other Qualifications:   Ability to work beyond core business hours as required.  

Travel: Travel as required (Approximately 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://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) 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.