General Description:
- At BeOne, our Global Development SuperHighway — our integrated, end-to-end, wholly internal development capability — is a cornerstone of our R D vision.
It brings together a unique set of internal cross-functional capabilities from across the globe needed for efficient delivery of clinical trials to develop impactful medicines to accelerate access to innovation for patients around the world. We are now opening this same delivery engine to the world's most promising external science. Through SuperHighway partnerships, highly promising assets from leading biotech partners can access our development capabilities creating a true win-win ecosystem with the ultimate goal of helping more patients around the world. This is not a fee-for-service model; it is a bold new way to grow the company and expand what's possible in oncology. This is a rare opportunity to help build something genuinely new — joining a high-caliber, agile team at the leading edge of clinical development innovation. If you are energized by building, by challenging the status quo, and by making a real impact on patients' lives, this is where you belong. The position contributes to the overall partnership program strategy and driving its vision and mission. Leveraging deep therapeutic and functional area expertise, the Regulatory Affairs Lead is accountable for developing, implementing, and advising on global regulatory strategies for development programs to secure and maintain market access for products in line with the partnership program's goals, and in coordination with key Advisory Committee and Execution Unit. The Lead manages all regulatory aspects of allocated assets through all phases of development, post-approval, and lifecycle of the product. The incumbent will provide leadership and strategic regulatory oversight for designated projects ensuring that the latest requirements and standards are met. This role helps deliver the partnership studies that run on our Clinical SuperHighway, supporting seamless onboarding and high-quality execution of external partner projects in close partnership with the execution functions.
- Essential Functions of the
Job:
- + Accountable for providing high level strategic and operational regulatory direction and mentorship on projects including, but not limited to general regulatory strategies, regulatory requirements for clinical studies and marketing approval in multiple countries, regulatory strategic development plans and risk assessments, critical issue management and advice on Health Authority interactions.
+ Use extensive knowledge of US, China, EU and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to allocated assets. + Oversee the preparation and submission of documentation to support investigational and marketing registration packages throughout the world and ensures timelines are met. + Review sections of IND/CTA, NDA/MAA/NDS, and other global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements. + Liaise and negotiate with global regulatory authorities as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals of product and labeling changes. + Maintain awareness of global regulatory environment and assess impact of changes on business and product development programs. Facilitate policy and development of standard interpretation of global regulation. + Integrates functional expertise with business knowledge to solve problems and make good decisions for the overall business. + Manages critical issues, taking leadership for the regulatory contribution. + Responsible for assisting with the development and implementation of regulatory processes. + Consult with Advisory Committee for relevant topics and incorporate the ideas into strategy and execution if appropriate. + Provide guidance to Execution Unit at regional and global level and ensure timely, quality, and efficient study planning and execution of associated clinical studies. + Conduct regular review meetings with Execution Unit to mentor, support, and ensure all studies are tracking to quality and timeline. + Report on study status, goals, operational KPIs, and enforce quality KPIs. + Champions a global mindset and approach across GRA to foster collaboration and consistency across the organization. + Participate company-wise standard discussion, finalization, and implementation. + Other duties as assigned.
Supervisory Responsibilities:
- N/A (individual contributor role; no direct reports).
Education Required:
- Bachelor's degree required; advanced degree preferred. A minimum of 12 years in the biotechnology or pharmaceutical industry and a minimum of 5 years in a regulatory leadership capacity with a broad background in oncology.
Computer Skills:
- Skilled in Microsoft Office Suite
Other Qualifications:
- + Experience of working as a lead in Regulatory Affairs across two or more major geographic areas, and experience of leading multiple FDA interactions for oncology products leading to Agency approval actions.
+ Experience should clearly be demonstrative of managerial, leadership, and collaboration ability across multiple functional areas. + Thorough understanding of drug development process, 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, 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 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. + Excellent interpersonal skills and the ability to build and maintain positive work relationships to effectively interface at all levels across the organization. + Fluent in written and verbal English.
Desirable:
knowledge of Mandarin.
Ability to travel domestically and internationally.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
