China Technical Regulatory (CMC) Policy Lead

About the role

Roche is looking for a China Technical Regulatory (CMC) Policy Lead in Beijing to provide leadership, oversight and execution of technical regulatory policy activities for the Roche Pharma Group in China. The role develops Roche's policy positions on key technical regulatory topics, advocates them externally, and works with regulatory colleagues in China and globally to build the China regulatory policy roadmap.

Key responsibilities

• Identify and enable regulatory policy activities in China so that Roche is seen by health authorities and industry peers as a leader, supporting pipeline development, marketing authorizations and manufacturing excellence.
• Build trusted relationships with key health authority professionals, academic and opinion leaders and non-profit scientific associations.
• Partner with internal stakeholders (Regulatory, Technical, Quality, Medical, Governmental Affairs) and external interest groups, and engage them on behalf of Roche.
• Develop, execute and communicate the China regulatory policy roadmap, leading cross-functional teams and regional/global regulatory communities of practice.
• Represent Roche's technical regulatory policy views externally and lead local, regional and global associations (e.g. RDPAC, BIO, IFPMA) and organizations (e.g. APEC, ICH).
• Advise Roche Pharma Division leaders on regulatory policy and strategy for China, and act as subject matter expert on assigned policy areas.

Required profile

• Degree in a relevant technical area (Analytical, Biochemistry, Biology, Pharmacy) or an advanced degree (PhD) in a relevant technical area combined with at least 5 years of work experience.
• At least 10 years of work experience in a relevant area.
• Previous regulatory (industry or agency) experience preferred; proven effectiveness in international regulatory/industry forums highly preferred.
• In-depth knowledge of the China regulatory environment.

Required skills

• Recognized expert in a relevant CMC technical/regulatory area with established external credibility as a thought leader.
• Excellent collaboration, advocacy, communication and presentation skills.
• Strategic thinking and analytical skills, able to simplify complex topics and lead cross-functional teams.
• Ability to work in a global matrix environment with shared accountability.