Senior Manager/Associate Director, Regulatory Affairs at BeOne Medicines in Seoul

Job description

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 functi