Senior Manager, Regulatory Affairs

Position Summary The Senior Regulatory Affairs Manager is responsible for developing and executing regulatory strategies to support the initiation of first-in-human clinical studies for oncology products in China. This role serves as a key regulatory partner to global and local cross-functional teams, ensuring compliance with CDE requirements while supporting business objectives and patient access to innovative therapies. The position requires strong regulatory expertise, strategic thinking, stakeholder management, excellent communication skills and leadership capabilities to successfully navigate an evolving regulatory environment and drive organizational Technical Competencies Regulatory Strategy & Execution • Develop and execute regulatory strategies to achieve timely submission and approval of clinical trial applications supporting oncology first-in-human clinical trials in China, including complex global clinical trials. • Provide regulatory guidance throughout the clinical trial application process and clinical trial execution • Lead preparation, review, and submission of regulatory dossiers for initial CTAs and amendments in compliance with CDE requirements. • Support accelerated approval pathways, breakthrough therapy programs, and innovative product designations where applicable. Regulatory Intelligence • Monitor and interpret changes in Chinese and global regulatory regulations, guidelines, and policies. • Assess regulatory impact on business operations and development programs. • Communicate emerging regulatory risks and opportunities to stakeholders. Health Authority Interactions • Lead regulatory interactions with CDE and other regulatory agencies. • Prepare briefing packages and coordinate regulatory meetings. Serve as point of contact for global Asset Strategy Team. • Develop effective negotiation strategies to facilitate successful regulatory outcomes. Quality and Compliance • Collaborate with Quality Assurance to maintain compliance with regulatory and quality system requirements. • Support inspections and audits when necessary. • Ensure regulatory documentation is maintained accurately and in accordance with company procedures. Soft Skills & Leadership Competencies Strategic Thinking & Business Acumen • Ability to align regulatory strategies with business priorities and product lifecycle objectives. • Strong understanding of the pharmaceutical industry, healthcare environment, and market access considerations. • Ability to identify opportunities and proactively address regulatory challenges. Stakeholder Management & Influencing Skills • Demonstrated ability to influence and collaborate with stakeholders across functions and organizational levels. • Strong partnership skills with, Clinical Development, Clinical Operations, Supply Chain, Manufacturing, Quality, and Global Regulatory teams. • Ability to build credibility and trusted relationships internally and externally. Communication Skills • Excellent verbal and written communication skills in both English and Chinese. • Ability to communicate complex regulatory concepts clearly to technical and non-technical audiences. • Strong presentation, negotiation, and advocacy skills. Collaboration & Enterprise Mindset • Strong cross-cultural and cross-functional collaboration skills. • Ability to balance local regulatory requirements with global business strategies. • Demonstrate a patient-centric mindset and commitment to ethical business practices. Key Responsibilities Regulatory Strategy • Develop and implement regulatory strategies for assigned oncology products to achieve business objectives and ensure timely clinical trial initiation in China. • Provide regulatory leadership and strategic guidance throughout the lifecycle of onco