Senior Director, Global Regulatory Affairs – Biotech Unit
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.
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:
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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.
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Use extensive knowledge of US, China, EU and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to allocated assets.
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Oversee the preparation and submission of documentation to support investigational and marketing registration packages throughout the world and ensures timelines are met.
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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.
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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.
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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.
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Integrates functional expertise with business knowledge to solve problems and make good decisions for the over