Manager, Regulatory Strategy & Business Planning

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Position Summary

• This role serves as a strategic anchor of the China Regulatory Affairs team. This position focuses on developing and implementing regulatory strategy and innovation, establishing goals and objectives (G&O), and driving business excellence and planning at the departmental level based on dynamic China regulatory environment.
• The incumbent also works closely with cross-functional teams to align China regulatory strategy with business objectives and priorities, support the department's work at the corporate level, continuously optimize processes, and ensure high-quality regulatory delivery.
• Strong business and medical/healthcare background, excellent cross-functional coordination capability and fluent English communication are essential for this role.

Key Responsibility

Regulatory Strategy & Implementation

• Provide forward‑looking insights and horizon‑scanning analyses to inform long‑term planning andportfolio strategy.
• Deliver business insights to support stakeholder engagement.
• Gather external industry cases and best practices to optimize regulatory strategy — including regulatorypathways, label strategy, and opportunities for pipeline assets — and translate these findings intoactionable execution plans that support leadership decision‑making.
• Identify operational pain points and propose systematic, sustainable improvement solutions to buildcapability and enable long‑term team development.

Business Planning & Excellence

• Support department leader on overall team annual business planning, workload prioritization, resourceallocation and strategic roadmap iteration.
• Drive regulatory business excellence initiatives, including process standardization, workflowoptimization, capability building and cross-project experience precipitation, to elevate overall teamefficiency and quality.
• Assist leadership in cross-departmental coordination, global-local alignment, and regular business review,functioning as a critical conduit for strategy incubation and internal implementation.
• Coordinate and host visits by global leaders, facilitating strategic briefings, stakeholder engagement, andactionable follow-ups.

Core competencies

• Strategic thinking: Strategic thinker with strong business acumen and an enterprise mindset. Strongunderstanding of the China regulatory environment and industry trends. Proactively identify external opportunities and empower business needs.
• Business acumen: Possess sharp business sense, with acute understanding of the impact of decisions taken. Proactively identify issues, assess risks and success probability, and provide actionable solutions and recommendations.
• Organizational capability: Ability to explore function-level requirements, support the function head to formulate function plans and goals, identify and resolve organizational pain points, drive operational efficiency.
• Synthesis & Narrative skills: Able to synthesize business needs and complex information into concise, well-structured narratives to support internal and external stakeholder communications and presentations.
• Learning skill: High learning agility, adaptable and open-minded, willing to work under high pressure and thrive in ambiguous, uncertain environments.

Education and Experience requirement

• A scientific background with an advanced degree in medical/healthcare discipline.
• Business management experience is preferred.

Other Comments:

• Proficient use of technology, including Microsoft Office programs and Internet resources.

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