Director, Regulatory Affairs

Company Description

Zai Lab is a patient-focused, innovative, commercial-stage, global biopharmaceutical company based in China and the United States. We are dedicated to discovering, developing, and commercializing best-in-class and first-in-class therapies that address medical conditions with significant unmet needs in oncology, immunology, neuroscience, and infectious disease. Guided by innovation and driven by purpose, our mission is to leverage our expertise and resources to make a lasting, positive impact on human health worldwide.

Zai Lab's global team of 2,100 talented professionals includes industry leaders and professionals dedicated to advancing novel therapies to patients. With headquarters in Cambridge, Massachusetts, and Shanghai, and teams in the U.S., China and Europe, we collaborate across time zones to deliver meaningful impact where it's needed most.

Founded in 2014 by Dr. Samantha Du, Zai Lab was purpose-built to become a leading global biopharma, combining scientific innovation, operational scale, and strong execution. Our global pipeline features ZL-1310, a DLL3 antibody-drug conjugate (ADC) with best-in-class and first-in-class potential in small cell lung cancer, now in clinical trials. At the same time, our R&D team is progressing several other global programs into the clinic, including ZL-1503, a bispecific IL-13/IL-31 antibody for atopic dermatitis, and ZL-6201, an LRRC15 ADC for solid tumors.

In China, we've earned a reputation as a partner of choice for leading global biopharmaceutical companies, leveraging our proven commercial infrastructure and clinical trial capabilities to accelerate market access to our innovative products. Due to its large population, China is the second largest pharmaceutical market in the world. Our unique business model combines in-licensed assets with strategic partnerships, leveraging our in-house research capabilities to build a regional portfolio of late-stage, potential best-in-class and first-in-class therapies. Today, with eight products on the market in China, we are delivering meaningful impact for patients and building opportunities for talented professionals to shape the future of medicine.

Zai Lab is publicly traded with dual-primary listings on both the Nasdaq Stock Market and the Hong Kong Stock Exchange, underscoring our commitment to transparency, global reach, and long-term growth.

Job Description

The Director, Regulatory Affairs is responsible for leading the development and execution of regulatory strategies for assigned assets, ensuring alignment and execution across regions. This role collaborates closely with other regulatory team members to prepare and manage submissions, leads interactions with health authorities, and ensures compliance with evolving regulatory requirements. Additionally, the Director serves as the US/EU regulatory lead, identifying and mitigating country-specific risks, supporting local submissions, and ensuring adherence to local regulations. The role involves representing Regulatory Affairs in cross-functional teams and governance forums.

This position reports to the VP, Regulatory Affairs (US/EU) and is based in our South San Francisco, CA office.

• Global Regulatory Strategy: Lead the development and execution of regulatory strategies for assigned assets, ensuring alignment and coordination across regions.
• Regulatory Submissions: Oversee the planning, preparation, and management of regulatory submissions for assigned programs, ensuring quality and timely delivery.
• Health Authority Engagement: Serve as a primary point of contact with FDA and EMA, leading or supporting meetings and communications. Ensures alignment of global Health Authority engagements with product strategy.
• Compliance: Ensure compliance with all applicable government regulations, industry guidelines, and internal policies for assigned programs.
• Regulatory Guidance: Interpret regulations, policies, and guidelines; advise cross-functional teams on regulatory requirements to support product development.
• Risk Management: Identify, assess, and proactively manage regulatory risks, developing and executing mitigation strategies.
• US/EU Regulatory expertise: Provide regulatory expertise for US and EU regions, identifying and mitigating country-specific risks, supporting local submissions, and ensuring adherence to local regulations.
• Cross-Functional Collaboration: Demonstrates a constructive and positive approach when working with colleagues. Encourages the exchange of information and the adoption of best practices. Represent Regulatory Affairs in cross-functional teams and governance forums, providing regulatory expertise throughout the product lifecycle.
• Regulatory Intelligence: Monitor and communicate changes in the regulatory environment and assess their impact on Zai Lab's portfolio.
• Process Improvement: Contribute to the enhancement of regulatory processes and systems for greater efficiency and compliance.
• Maintains the highest standards of integrity and ethics. Contribute to building an open and trust atmosphere. Ability to work across several time zones and travel up to 30%.

Qualifications

REQUIRED

• Bachelors degree in life sciences with a minimum of 12 years of regulatory affairs experience in the biopharmaceutical industry; or equivalent combination of higher education, training and experience.

PREFERRED

• Advanced degree in life sciences, pharmacy, or a related field (PhD, PharmD, MS, or equivalent).
• Prior BLA/MAA experience is strongly preferred.
• Demonstrated success in developing and executing regulatory strategies across different stages of development.
• Proven experience leading health authorities interactions and negotiations, and managing regulatory submissions
• Strong knowledge of regulatory requirements and processes in major markets.
• Ability to interpret and apply regulations, policies, and guidelines to support product development.
• Excellent organizational, communication, and interpersonal skills.
• Strong analytical and problem-solving abilities, with a proactive approach to risk management.
• Experience representing Regulatory Affairs in cross-functional teams and governance forums.
• Ability to work effectively in a fast-paced, matrixed, and global environment across several time zones

Additional Information

The pay range for this position at commencement of employment is expected to be between $221K and $246K/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 Lab, 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, 59% of our employees are women and 53% 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.

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