China Technical Regulatory (CMC) Policy Lead

Regulatory Policy Lead, China

Roche is seeking a Regulatory Policy Lead to provide leadership, oversight, and execution of technical regulatory policy activities for the Roche Pharma Group in China. The role involves developing policy positions, advocating externally, and collaborating with global and local teams to execute the China regulatory policy roadmap.

Key Responsibilities

• Identify and enable regulatory policy activities to establish Roche as an industry leader.
• Build and maintain relationships with health authorities, academic leaders, and scientific associations.
• Partner with internal stakeholders across Regulatory, Technical, Quality, Medical, and Government Affairs.
• Lead cross-functional teams to drive policy change and represent Roche in industry forums like RDPAC, BIO, or IFPMA.
• Act as a subject matter expert and provide strategic consultancy to leadership.
• Build advocacy capacity within the organization to shape the regulatory environment.

Requirements

• Degree in a relevant technical area such as Analytical Chemistry, Biochemistry, Biology, or Pharmacy.
• At least 10 years of work experience in a relevant field, or a PhD with at least 5 years of experience.
• In-depth knowledge of the China regulatory environment.
• Proven ability to build relationships with global health authorities and experience in regulatory affairs (industry or agency).
• Strong strategic thinking, communication, and advocacy skills with the ability to operate in a global matrix environment.