Senior Group Director, Technical Regulatory Affairs

The Project People Leader manages a team of China Technical Partners and CMC professionals, overseeing end-to-end China regulatory CMC submissions for the Roche portfolio. This role focuses on accelerating drug access by developing robust filing strategies, ensuring high-quality submissions to Chinese Health Authorities, and shaping the regulatory environment. The leader is responsible for performance management, coaching, and mentoring team members, while collaborating cross-functionally to align regulatory strategies with business priorities.

Responsibilities

• Provide leadership, performance management, and coaching to a team of regulatory professionals.
• Coordinate resources and priorities at a portfolio level in collaboration with the Portfolio Leader.
• Develop submission strategies, identify regulatory risks, and create mitigation plans for specific projects.
• Build and maintain relationships with internal and external stakeholders, including NMPA, CDE, and NIFDC.
• Collaborate with internal stakeholders to align technical strategies with regulatory and supply needs.

Requirements

• Master’s degree in life sciences preferred; post-graduate degree is a plus.
• 8+ years of experience in the pharmaceutical or biotechnology industry, specifically in CMC, quality, or regulatory affairs.
• Previous people management or cross-functional team leadership experience.
• Strong knowledge of China Health Authority guidelines and experience in regulatory interactions.
• Technical understanding of drug substance and product manufacturing, drug development, and supply chain complexity.
• Proven ability to develop regulatory strategies, perform risk assessments, and drive continuous improvement.
• Excellent communication, influencing, and negotiation skills with the ability to synthesize complex issues for decision-making.