Project People Leader

Job title: Project People Leader

About the Role Lead a team of China Technical Partners (CTPs) and CMC professionals accountable for China regulatory CMC submissions, shaping the regulatory environment in China in collaboration with PTR Policy and translating policy into actionable regulatory strategies. This role supports Roche's China strategy and the China First initiative to accelerate drug access and ensure continuous supply with right-first-time submissions and effective Health Authority interactions.

What You'll Do

• Provide leadership to a team of regulatory professionals (CTPs and CMC program managers), set performance objectives, deliver timely feedback, and align short- and long-term development goals.
• Develop and implement end-to-end China filing strategies for the Roche portfolio, collaborating with global development teams, China business priorities, and regulatory requirements.
• Lead and coach team members to accelerate drug access, ensure right-first-time submissions, and manage Health Authority interactions.
• Proactively drive cross-functional regulatory initiatives and strategies, defining critical steps, resources, and migration plans; maintain alignment with Portfolio Leader on priorities.
• Communicate with regulatory and cross-functional teams to support internal and partner project goals; collaborate with HA on complex projects.
• Shape the regulatory environment in China in collaboration with PTR Policy and translate into innovative regulatory strategies; align with Roche China strategy and the China First initiative.
• Build and maintain healthy relationships with internal/external stakeholders (NMPA, CDE, NIFDC, Supply Chain, Quality & Compliance, PDR China, PTR Global) and align technical strategy with regulatory and supply needs.
• Manage resource allocation at the Portfolio level; follow up on project progress; identify regulatory risks and develop migration/mitigation plans.
• Lead communications with Health Authorities on major initiatives and ensure submission readiness and compliance.

What We're Looking For

• Master’s degree in life sciences; Postgraduate degree preferred.
• 8+ years in pharmaceutical/biotech with CMC, regulatory, or related experience; prior people management experience desired.
• Deep regulatory strategy knowledge; strong understanding of China Health Authority guidelines and experience interacting with health authorities.
• Technical understanding of drug substance/product manufacturing; SM and/or LM, and product development processes; knowledge of drug development, commercialization, supply chain, and Pharmaceutical Quality Systems.
• Agile mindset and drive for continuous improvement; ability to work across functions.
• Proven collaboration and leadership skills; track record of building cross-functional teams and coaching employees; strong organizational and time management abilities.
• Exceptional influencing and negotiation skills; strong written and verbal communication; ability to synthesize complex issues and present to stakeholders.
• Demonstrates Roche values and leadership competencies.

Nice to Have

• Postgraduate degree is a plus.

Compensation & Benefits

• Not disclosed in the posting.