Senior Manager/Associate Director, 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:

The Senior Manager/Associate Director, Regulatory Affairs is a senior member of the Korea Regulatory Affairs team, reporting to the Head of Regulatory Affairs, Korea. This role provides strategic regulatory leadership for assigned products and development programs across the product lifecycle, from clinical development and product registration through post-approval lifecycle management.

The position will work closely with global, regional, and local cross-functional teams to anticipate regulatory requirements, identify and manage regulatory risks, and develop effective regulatory solutions to support development and business objectives.

The position will also have people management responsibilities, providing leadership, coaching, and development to members of the Korea Regulatory Affairs team.

Essential Functions of the Job:

·       Develop and execute regulatory strategies across the product lifecycle, from clinical development and initial marketing authorization through post-approval lifecycle management, in alignment with global/regional strategies and Korean regulatory requirements.

·       Lead and oversee regulatory activities for assigned products and development programs in Korea, including clinical trial applications, marketing authorization applications, major variations, and other regulatory submissions, ensuring high-quality and timely execution.

·       Lead key interactions with Korea Health Authority, including regulatory consultations and meetings, responses to authority questions, and resolution of complex regulatory issues to facilitate timely approvals.

·       Provide expert regulatory input into strategic decision-making, including development strategy, portfolio review and prioritization, regulatory risk assessment, and external communications.

·       Proactively identify, assess, and communicate regulatory risks and opportunities, and develop appropriate mitigation strategies in collaboration with global, regional, and local stakeholders.

·       Collaborate effectively with global, regional, and local cross-functional teams to ensure regulatory strategies and activities are aligned with development and business objectives.

·       Maintain up-to-date knowledge of Korean regulatory requirements, guidelines, and regulatory trends, assess their potential impact on the company’s products and development programs, and provide regulatory intelligence and guidance to relevant stakeholders.

·       Ensure that registered products and clinical trials remain in compliance with applicable Korean regulations, regulatory commitments, internal SOPs, and local working practices.

·       Develop, implement, and maintain regulatory procedures and local working practices to support regulatory compliance, operational effectiveness, and inspection readiness.

·       Provide senior regulatory leadership for regulatory inspections, audits, product recalls, and other significant regulatory or compliance matters, and provide senior regulatory leadership across functions as required.

·       Manage, coach, and develop members of the Korea Regulatory Affairs team, providing clear direction, ongoing feedback, and professional development while fostering a collaborative and high-performing team environment.

Qualification Required:

Education Required:

B.S. in Pharmacy or Life Sciences

Other qualifications:

·       Computer Skills: Experience in working with MS office in a Windows environment

·       Negotiating, communication and interpersonal skills

·       Fluency in written and spoken English

·       Experiences of people management (preferred)

Supervisory Responsibilities:  

·       Manage, coach, and develop members of the Korea Regulatory Affairs team

Computer Skills:   Experience in working with MS Office in a windows environment

Travel:  15%

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 in Workday (currently located in the U.S.). Besides, job applicants’ data will be kept for one year 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.