Manager – Regulatory Affairs

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:

Provides strategic regulatory leadership throughout product development, submission, approval, and lifecycle management. Develops and drives project-specific regulatory strategies and longer-term regulatory plans with minimal oversight.

Independently evaluates regulatory risks, alternative strategies, and submission pathways, and provides clear recommendations to project teams and management. Leads cross-functional discussions to align regulatory strategy with development plans, business priorities, and submission timelines.

Owns project-level regulatory deliverables and proactively identifies, communicates, and escalates critical issues to line managers or subject matter experts, as appropriate. Directly contributes to regulatory compliance, quality, and timely delivery across assigned projects.

Essential Functions of the Job:

• Independently lead complex submissions, including NDA/sNDA, BLA/sBLA, IND/CTA, and lifecycle management activities, in collaboration with line management and subject matter experts as appropriate.
• Develop and maintain project-specific regulatory strategies and longer-term regulatory plans based on product development objectives, Taiwan regulatory requirements, and relevant regulatory trends.
• Evaluate alternative regulatory strategies and submission pathways, including associated risks, benefits, dependencies, and potential impact on development and approval timelines.
• Provide clear regulatory recommendations and scenario-based options to support business and project decision-making.
• Apply strong knowledge of regulations, guidelines, and regulatory frameworks to both routine activities and complex or non-routine regulatory issues.
• Lead and facilitate cross-functional discussions to align regulatory strategy, submission requirements, responsibilities, and timelines.
• Serve as a regulatory representative in project teams and provide proactive regulatory guidance to relevant functions.
• Identify emerging regulatory risks, opportunities, and changes in the Taiwan regulatory environment, and assess their potential impact on assigned products and development plans.
• Build and maintain effective working relationships with internal stakeholders, external partners, and health authorities, as applicable.
• Contribute to improvements in regulatory processes, planning, knowledge sharing, and operational efficiency within the scope of responsibility.
• Prepare and deliver clear written and verbal regulatory recommendations, project updates, risk assessments, and management communications.
• Communicate effectively in English in cross-functional discussions and internal documentation.

Supervisory Responsibilities:  

• No direct people-management responsibility is required at the time of appointment.
• May provide guidance, coaching, and functional support to junior team members, contractors, or project support resources, as assigned.
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Qualification Required:

Education Required: At least a BS in pharmacy, biological science, or another health-related discipline.

Computer Skills:  MS Office skills, including Outlook, Word, Excel, and PowerPoint.

Other Qualifications:   

·        Thorough understanding of IND/CTA, NDA/BLA, and lifecycle management processes, with strong knowledge of ICH and associated regulatory guidelines. 

·        Demonstrated experience developing regulatory strategies, assessing alternative submission pathways, and translating regulatory requirements into practical project plans. 

·        Strong cross-functional leadership, influencing, and stakeholder-management skills. 

·        Ability to communicate complex regulatory considerations clearly and facilitate alignment across functions. 

·        Strong business acumen and understanding of Taiwan regulatory trends and their potential impact on development and commercialization plans. 

·        Excellent organizational skills and ability to prioritize and manage multiple complex projects. 

·        Typically, a minimum of 5-7 years of regulatory affairs experience, or equivalent relevant experience, including experience independently supporting complex regulatory projects and submissions. 

Travel:  Some travel may be required, less than 10%.

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

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.