Senior Director, Regulatory CMC

Job Description

Job Description

Company Description

Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States focused on bringing transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders to patients in China and around the world. Our goal is to leverage our competencies and resources to positively impact human health worldwide.

Founded in 2014, our experienced team has secured partnerships with leading global biopharmaceutical  companies, generating a broad and late-stage pipeline of innovative drug candidates. Based on our proven  track record of  success, Zai Lab has earned the reputation as a trusted partner of choice for global biopharmaceutical companies seeking to not only access the Chinese market but also find a long-term strategic partner for global clinical development.  Our unique business model builds on our in-licensed assets and innovative partnerships to expand our internal discovery and development capabilities and has created a portfolio of potential best-in-class and/or first-in-class therapies. Zai currently 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 2022, Zai Lab became dual-primary listed on both the Nasdaq and the Hong Kong Stock Exchanges. Since its inception, Zai Lab has expanded significantly with several offices across China. 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.

Primary Function:

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 the regulatory agencies’ requests.

This role is based in our South San Francisco, CA office.

Major Responsibilities and Duties:

• 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 (change control, deviation regulatory evaluation, etc.).

• Act as the primary CMC contact for interactions with health authorities (e.g., NMPA, CDE, FDA, EMA) 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 (ICH, NMPA, FDA, EMA, etc.).

• 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 (e.g., QA/QC, R&D, manufacturing) and external partners to deliver high-quality dossiers and support business priorities.

REQUIRED:

• PHD in scientific discipline with eight years of regulatory experience; or equivalent combination of education, training and experience. RAC certification is a plus.

• Excellent verbal and written communication skills in both English and Chinese, with the ability to articulate complex regulatory issues clearly and concisely.

PREFERRED:

• 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.

The pay range for this position at commencement of employment is expected to be between $258k and $320K/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

At Zai, we are 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.

Disclaimer: This description is not intended to be construed as an exhaustive list of duties, responsibilities, or requirement for the position. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

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 committed to protecting the privacy and security of the information we collect and to being transparent about the purposes for which we use your information. We have a Privacy Notice which sets forth our policies and practices for handling the information we collect and use in the employment context.  Privacy Notice available upon request.