Senior Manager/Associate Director, Regulatory Affairs (Hong Kong, Macao)

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 responsible for leading regulatory strategies, registrations, lifecycle management, regulatory intelligence, and Health Authority engagement activities for BeOne's portfolio in Hong Kong and Macau. This role serves as the primary regulatory representative for Hong Kong and Macau, partnering with internal and external stakeholders to support business growth, accelerated patient access, regulatory compliance, and policy advocacy initiatives. The position also serves as the local Pharmacovigilance (PV) Contact Person for Hong Kong. Essential Functions of the Job: Regulatory Strategy & Portfolio Management Develop and implement regulatory strategies to support product registrations, lifecycle management, and accelerated market access. Provide strategic regulatory input to portfolio planning, launch readiness, and business decision-making. Assess regulatory risks and opportunities and recommend appropriate mitigation strategies. Health Authority Engagement Serve as the primary contact with Health Authorities in Hong Kong and Macau. Lead regulatory interactions, negotiations, and agency engagements to support timely approvals and business objectives. Proactively manage regulatory review activities and key regulatory issues. Regulatory Intelligence & Policy Advocacy Monitor and interpret regulatory developments and assess impacts on the business. Communicate emerging regulatory trends, risks, and opportunities to stakeholders. Support policy shaping and external stakeholder engagement activities. Cross-functional Leadership Collaborate with Global Regulatory Affairs, Medical Affairs, Commercial, Market Access, Pharmacovigilance, Quality, and external partners to achieve regulatory and business objectives. Represent Hong Kong and Macau in regional and global project teams and governance forums. Compliance & Pharmacovigilance Ensure ongoing regulatory compliance and support inspections, audits, and regulatory commitments. Serve as the local PV Contact Person and ensure compliance with local pharmacovigilance requirements. Qualification Required: Education Required: Bachelor’s degree required, advanced degree preferred Core Competencies , Knowledge and Skill Requirements : Minimum 10 years of RA and relevant experience in the biotechnical or pharmaceutical industry. Preferred candidates will have experience working as a lead in Regulatory Affairs across two or more major geographic areas, 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 INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, interactions with 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 oral and written communication skills. Could take the Influence and Advisory Role in regulatory team: Exerts influence at the departmental levels, serving as an advisor/liaison to GRA and CRA management to plan, evaluate, and recommend regulatory strategies. Excellent Regulatory Cross-role Collaboration and Coordination Leadership: Builds partnerships with key stakeholders from other regulatory roles to ensure strategic business goals are met through shared knowledge and expertise. Excellent command of written and oral English, Cantonese, and Mandarin Ability to prioritize and handle multiple projects simultaneously. Interacts with BeOne employees and senior management. Interacts with external business partners and Regulatory Agencies. 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 applican