General Description: The Senior Director, Head of Regulatory Affairs, Asia Pacific will be responsible for developing, implementing, and advising on APAC regulatory strategies for development programs to secure and maintain market access for product(s) in Asia Pacific region in line with business objectives, and in coordination with key internal stakeholders. This individual will manage regulatory aspects of compounds through all phases of development, post-approval, and lifecycle of the product. This role will directly manage a team of regulatory affairs professionals across a range of levels and assets and must be equally adept at providing technical as well as professional growth and leadership to the team. The position could be in major countries Beigene has presence.

Essential Functions of the job: l Build and lead the Asia Pacific regulatory team across various locations in the region. l Supervise team members and external vendors to the Regulatory Affairs function and provide management and guidance across the function. l Manage the Asia Pacific regulatory team activities, budget and staff including identifying, hiring and training additional staff as needed. l Represent Asia Pacific RA team within the BeiGene Global Regulatory Leadership. Work in close collaboration with BeiGene Global functions to integrate all aspects of Asia Pacific and APAC regulatory strategy. l Drive Regional Regulatory Affairs strategy and execution for the organization across key focus areas in hematology and solid tumours. l Ensure that the interactions between Regulatory and other functions in the Asia Pacific region are managed optimally. Work in close collaboration with Asia Pacific functional heads to integrate regulatory within clinical development, commercial, medical and market access etc initiatives and strategies. l Oversees regulatory aspects of submissions and communications with the respective Health Agencies by departmental staff. Manage timelines and resources to achieve stated objectives, ensuring tracking tools and regulatory databases are maintained up to date. l Oversees strategic placements of key Asia Pacific countries in global clinical development plans. l Provide strategic regulatory support to internal brand, product and project teams. Pro-actively communicate the latest regulations, guidance, and actions from Asia Pacific countries and competitors that may influence the landscape and assesses the potential impact on regulatory and/or business strategy and planning. Contributes to the development and implementation of processes and procedures relevant to l the operations of the regulatory function and its interactions with internal stakeholders. l Oversee all operational aspects of regulatory submissions, including maintaining timelines and developing and coordinating submission content for various regulatory agency applications, safety, amendments, and IND safety and annual reports. Represents BeiGene in industry associations relevant to the Asia Pacific region.

Supervisory Responsibilities: l Manage a team of RA strategists in the region.

Qualifications: l A minimum of 12 years in the biotechnology or pharmaceutical industry and a minimum 8 years in a Regulatory leadership capacity with a broad background in oncology. l Knowledge of Inflammation and Immunology a plus. Preferred candidates will have experience working as a lead in Regulatory Affairs across two or more major geographic areas, prior experience with both small molecules and biologics l Experience leading multiple HA interactions leading to Agency approval actions. l Experience should clearly be demonstrative of managerial, leadership, and collaboration ability across multiple functional areas.

Computer Skills: Microsoft Words, Excel, PowerPoint Other Qualifications: Veeva regulatory publishing Travel: Expectation of occasional travel