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 oncology early development studies.
Clinical Trial Application Submission and Approval
Lead preparation, compilation, review, and submission of regulatory applications to CDE and other relevant authorities.
Coordinate cross-functional activities required to support product registrations and approvals.
Manage regulatory agency interactions and address questions arising during the review process.
Regulatory Intelligence and Policy
Monitor regulatory developments and assess their impact on company products and business operations.
Provide strategic recommendations regarding new regulations, guidelines, and industry trends.
Participate in industry associations and regulatory forums to influence policy discussions and maintain regulatory awareness.
Cross-Functional Partnership
Collaborate with global and local stakeholders to ensure alignment of regulatory strategies and business objectives.
Provide regulatory expertise to local and global project teams.
Compliance and Quality Support
Partner with Quality Assurance to maintain regulatory compliance and quality system effectiveness.
Support audits, inspections, and corrective actions as required.
Reporting and Governance
Provide regular updates to senior management regarding regulatory project status, risks, and mitigation plans.
Maintain accurate regulatory records and ensure compliance with internal governance requirements.
Key Success Factors
Strong regulatory expertise and strategic mindset.
Excellent leadership, communication and stakeholder management capabilities.
Ability to influence decisions in a matrix organization.
High level of integrity, accountability, and patient focus.
Proven ability to deliver results in a complex and evolving regulatory environment.
Commitment to continuous learning and professional development.
Education
Bachelor's degree or above in Pharmacy, Medicine, Pharmacology, Biology, Chemistry, Life Sciences, or a related scientific discipline.
Advanced degree (Master's, PharmD, PhD, or equivalent) preferred.
Experience
Minimum 10 years of regulatory affairs experience within the pharmaceutical industry.
Significant experience in China regulatory submissions, approvals, and lifecycle management.
Proven experience developing and implementing regulatory strategies for innovative pharmaceutical products.
Oncology therapeutic area experience required, with early oncology clinical development experience strongly preferred.
Experience interacting directly with CDE, and other health authorities.
Experience working within a multinational pharmaceutical company environment is highly desirable.
Demonstrated experience leading complex cross-functional projects.

Employment type
Full-time

Work arrangement
Hybrid