Senior Manager, Regulatory Affairs

Position Summary

The Senior Regulatory Affairs Manager is responsible for developing and executing regulatory strategies to support the registration, approval, lifecycle management, and commercialization of oncology products in China. This role serves as a key regulatory partner to global and local cross-functional teams, ensuring compliance with National Medical Products Administration (NMPA) requirements while supporting business objectives and patient access to innovative therapies.

The position requires strong regulatory expertise, strategic thinking, stakeholder management, and leadership capabilities to successfully navigate an evolving regulatory environment and drive organizational success.

Key Responsibilities

Regulatory Strategy

1. Develop and implement regulatory strategies for assigned oncology products to achieve business objectives and ensure timely market access in China.
2. Provide regulatory leadership and strategic guidance throughout product development, registration, and commercialization.

Product Registration and Approval

1. Lead preparation, compilation, review, and submission of regulatory applications to NMPA and other relevant authorities.
2. Coordinate cross-functional activities required to support product registrations and approvals.
3. Manage regulatory agency interactions and address questions arising during the review process.

Lifecycle Management

1. Ensure timely execution of all post-approval regulatory activities, including variations, renewals, labeling updates, and commitments.
2. Maintain product licenses and registrations in compliance with regulatory requirements.

Regulatory Intelligence and Policy

1. Monitor regulatory developments and assess their impact on company products and business operations.
2. Provide strategic recommendations regarding new regulations, guidelines, and industry trends.
3. Participate in industry associations and regulatory forums to influence policy discussions and maintain regulatory awareness.

Cross-Functional Partnership

1. Collaborate with global and local stakeholders to ensure alignment of regulatory strategies and business objectives.
2. Support product launch planning, portfolio management, and lifecycle optimization activities.
3. Provide regulatory expertise to commercial, medical, clinical, and market access teams.

Compliance and Quality Support

1. Partner with Quality Assurance to maintain regulatory compliance and quality system effectiveness.
2. Support audits, inspections, post-market surveillance activities, and corrective actions as required.

Reporting and Governance

1. Provide regular updates to senior management regarding regulatory project status, risks, and mitigation plans.
2. Maintain accurate regulatory records and ensure compliance with internal governance requirements.

Key Success Factors

• Strong regulatory expertise and strategic mindset.
• Excellent leadership 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.