General Description:
- The 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 the Asia Pacific region in line with business objectives, and in coordination with key internal stakeholders.
- This individual will oversee the management of regulatory deliverables to support 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 must be equally adept at providing technical as well as professional growth and leadership to the team.
- The position could be located in major countries BeOne has presence in the Asia Pacific region.
Essential Functions of the job:
- Build and lead the Asia Pacific regulatory team across various locations in the region commensurate with the expansion of BeOne's commercial footprint.
- Supervise team members and external vendors to the Regulatory Affairs function and provide management and guidance across the function.
- Manage the Asia Pacific regulatory team activities, budget and staff including identifying, hiring and training additional staff as needed.
- Represent Asia Pacific RA team within the BeOne Global Regulatory Leadership. Work in close collaboration with BeOne Global functions to integrate all aspects of Asia Pacific and APAC regulatory strategy.
- Drive Regional Regulatory Affairs strategy and execution for the organization across key focus areas in hematology, solid tumours and Inflammation & Immunology.
- 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.
- 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.
- Oversees strategic placements of key Asia Pacific countries in global clinical development plans.
- 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 the operations of the regulatory function and its interactions with internal stakeholders.
- 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 BeOne in industry associations relevant to the Asia Pacific region.
- Represents APAC Regulatory at the cross functional APAC leadership team.
Professional Qualifications and Experience:
- 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.
- Experience in a multinational pharmaceutical/biotechnology company.
- Knowledge of Inflammation and Immunology is a plus. Preferred candidates will have experience working as a lead in Regulatory Affairs across at least two major geographic areas in APAC, with prior experience in both small molecules and biologics.
- Experience leading multiple HA interactions leading to Agency approval actions.
- Experience should clearly be demonstrative of managerial, leadership, and collaboration ability across multiple functional areas.
- Experience leading regulatory successes in the APAC region.
Supervisory Responsibilities:
- Yes, manage a team of RA strategists in the APAC region.
Computer Skills: Microsoft Words, Excel, PowerPoint.
Other Qualifications: Veeva regulatory publishing.
Travel: Expectation of occasional travel.
