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About the Role

Responsible for leading the global CMC regulatory strategy and execution for both small molecule and biological projects across all phases of development, including strategy, dossier preparation and submissions, and responses to regulatory agencies’ requests.

Responsibilities

• Lead the preparation of global CMC regulatory submissions for both small molecules and biologics, including IND/CTA, NDA/BLA/MAA applications.
• Oversee the end-to-end CMC dossier preparation, review, and finalization, ensuring scientific soundness, data integrity, and regulatory compliance across all product modalities.
• Develop and implement comprehensive regulatory CMC strategies to facilitate the progress of programs in all phases of development, with focus on late-stage development and post-approval regulatory support for all GMP-related activities.
• Act as the primary CMC contact for interactions with health authorities on CMC-related issues, including leading pre-IND/NDA/BLA meetings and responses to regulatory questions.
• Lead regulatory risk assessment, identify key CMC issues, and define mitigation activities throughout the product lifecycle.
• Provide strategic regulatory CMC guidance to cross-functional project teams to ensure development activities comply with relevant guidelines and governmental regulations.
• Ensure that the content and format of regulatory submissions comply with applicable regulations and guidelines.
• Lead and manage a team of CMC regulatory professionals, including mentoring, performance management, and career development.
• Contribute to the development of internal regulatory CMC guidance, working instructions, and process improvements to enhance dossier quality and review efficiency.
• Maintain up-to-date knowledge of evolving regulatory requirements, guidelines, and technical trends in both small molecule and biologics CMC domains.
• Collaborate effectively with internal stakeholders and external partners to deliver high-quality dossiers and support business priorities.

Requirements

• PHD in scientific discipline with eight years of regulatory experience; or equivalent combination of education, training and experience.
• Excellent verbal and written communication skills in both English and Chinese, with the ability to articulate complex regulatory issues clearly and concisely.
• Deep scientific understanding of both small molecule and biologics CMC principles, including development processes, manufacturing, and controls.
• Thorough knowledge of international regulatory requirements and guidelines, including ICH, NMPA/CDE, FDA, and EMA, with proven experience in global submissions.
• Proven track record of leading CMC regulatory submissions (INDs, NDAs, BLAs) and successful interactions with health authorities.
• Demonstrated leadership success as a people manager with experience in building and developing teams.
• Strong strategic thinking, creative problem-solving, and decision-making abilities.
• Detail-oriented with strong project management, negotiating, and interpersonal skills.

Skills

• CMC regulatory strategy
• Dossier preparation
• Regulatory submissions (IND/CTA, NDA/BLA/MAA)
• Health authority interactions
• Regulatory risk assessment
• Cross-functional team guidance
• ICH guidelines
• NMPA regulations
• FDA regulations
• EMA regulations
• Team leadership
• Process improvement
• Project management
• Negotiating skills
• Interpersonal skills
• English communication
• Chinese communication

Location

• South San Francisco, CA

Work Type

• Full-time

Experience Level

• 8 years of regulatory experience

Education Level

• PHD
• RAC certification is a plus

Salary/Compensations

• $258k - $320K/year

Benefits

• Sign-on bonus
• Restricted stock units
• Discretionary awards
• Full range of medical benefits
• Financial benefits
• 401(k) eligibility
• Various paid time off benefits (vacation, sick time, parental leave)

About the Company

• Zai Lab Limited is an innovative, research-based, commercial-stage biopharmaceutical company focused on bringing transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders to patients in China and around the world.
• The company has secured partnerships with leading global biopharmaceutical companies, generating a broad and late-stage pipeline of innovative drug candidates.
• Zai Lab has earned the reputation as a trusted partner of choice for global biopharmaceutical companies seeking to access the Chinese market and find a long-term strategic partner for global clinical development.
• The company's unique business model builds on in-licensed assets and innovative partnerships to expand internal discovery and development capabilities.
• Zai Lab has four products on the market in China.
• Zai Lab was successfully listed on the Nasdaq Stock Market in September 2017 and completed secondary listing on Hong Kong Stock Exchange in September 2020.
• In 2021, Zai Lab established its U.S. Headquarters in Cambridge, Massachusetts.
• As of January 2022, the Company has a global team of approximately 2000 employees.

Equal Opportunity

• All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability.
• Zai Lab is proud of the gender diversity of our company and our promotion of women in biotech.
• We have achieved gender base pay equity at all levels, 58% of our employees are women and 54% of our management positions are held by women.
• We are committed to the health of patients and our planet. That’s why our environmental protection, social responsibility, and corporate governance strategy, called “Trust for Life” is integrated within our business.