Global CMC Regulatory Strategy Director

Zai-Lab-; South San Francisco (CA); On-site; USD 258,000 - 320,000; Full time

Job summary

Zai Lab Limited seeks a senior CMC regulatory leader to drive global regulatory strategy for both small molecules and biologics from its South San Francisco office. You will oversee IND/CTA and NDA/BLA submissions, coordinate with health authorities, and guide cross-functional teams across development stages.

The role requires strong leadership, deep CMC knowledge, and fluency in English and Chinese, with a track record of successful global submissions and regulatory interactions.

Qualifications

• PhD in scientific discipline with eight years of regulatory experience.
• RAC certification is a plus.
• Excellent verbal and written communication skills in English and Chinese.
• Deep scientific understanding of CMC for both small molecules and biologics.
• Knowledge of ICH, NMPA/CDE, FDA, EMA with global submissions.
• Proven track record leading CMC regulatory submissions (INDs, NDAs, BLAs) and interactions with health authorities.
• Demonstrated leadership as a people manager.

Responsibilities

• Lead global CMC regulatory submissions for small molecules and biologics (IND/CTA, NDA/BLA/MAA).
• Oversee end-to-end dossier preparation, review, and finalization.
• Develop and implement CMC regulatory strategies for all development stages.
• Act as primary CMC contact with health authorities (FDA, EMA, NMPA, etc.).
• Lead regulatory risk assessment and mitigation across product lifecycles.
• Provide strategic CMC guidance to cross-functional teams.
• Ensure submissions comply with applicable guidelines (ICH, NMPA, FDA, EMA).
• Mentor and manage a team of CMC regulatory professionals.
• Contribute to internal regulatory guidance and process improvements.
• Stay updated on evolving regulatory requirements.

Skills

Regulatory leadership

Excellent communication

People management

Education

PhD in scientific discipline

Job description

Zai Lab Limited seeks a senior CMC regulatory leader to drive global regulatory strategy for both small molecules and biologics from its South San Francisco office. You will oversee IND/CTA and NDA/BLA submissions, coordinate with health authorities, and guide cross-functional teams across development stages.

The role requires strong leadership, deep CMC knowledge, and fluency in English and Chinese, with a track record of successful global submissions and regulatory interactions.