Senior Group Director, Technical Regulatory Affairs

About the role

Roche is looking for a Senior Group Director, Technical Regulatory Affairs in Beijing. The role leads a team of China Technical Partners (CTPs) and CMC professionals responsible for China regulatory CMC submissions, covering the complete Roche portfolio including small molecules, biologics and new modalities. It is a people leader position with a high business impact, focused on accelerating drug access and supply by securing right-first-time submissions to Chinese Health Authorities.

Key responsibilities

• Manage China Technical Partners and CMC program managers, set performance objectives, give timely feedback and align short-term goals with longer-term career goals.
• Lead and coach the team, provide mentoring and adapt coaching style to individual needs.
• Shape the regulatory environment in China with PTR Policy and turn it into regulatory strategies.
• Lead cross-functional regulatory initiatives, define steps and resources, and implement them.
• Follow up on every project, help the team build submission strategies, identify regulatory risks and develop migration plans.
• Maintain relationships with internal and external stakeholders such as NMPA, CDE, NIFDC, Supply Chain, Quality and Compliance, PDR China and PTR global.
• Work with the Portfolio Leader to coordinate resources and priorities, and collaborate with management on communications with health authorities.

Required profile

• 8+ years of experience in the pharmaceutical, biotechnology or related industry, in CMC, quality, regulatory or related fields.
• Previous people management or cross-functional team leadership experience is desired.
• Master's degree in life sciences preferred; postgraduate degree a plus.

Required skills

• Knowledge of China Health Authority guidelines and experience interacting with health authorities.
• Track record of developing regulatory strategies and scenario planning with regulatory risk assessment.
• Technical understanding of drug substance and product manufacturing in small molecule and biologic modalities, and of drug development, quality systems and supply chain.
• Team leadership, coaching and mentoring, and strong stakeholder management.