Executive Director, Regulatory Affairs

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.

Job Description

The Executive Director of Regulatory Affairs provides regulatory affairs strategy and oversight of US operations.  This position also has a significant role supporting global regulatory strategy and activities and works closely with other senior Zai Project Team leadership to offer regulatory strategic inputs.   

• Develops and implements the regulatory strategy for US
• Ensures compliance with all appropriate government regulations and industry guidelines
• Serves as the regulatory lead for one or more programs, leading the planning and execution of regulatory submissions for the program(s)
• Interprets regulations, policies and guidelines and advises cross-functional teams on regulatory requirements to support development
• Anticipates regulatory obstacles and emerging issues throughout the development lifecycle and creates solutions
• Provides risk assessments, oversees and manages the preparation of regulatory submissions
• Represents Zai Lab as point of contact with regulatory authorities
• Build and retain effective regulatory team, supervise and coach team members
• Prepares department budgets and identify appropriate external resources as needed

Qualifications

REQUIRED:

• Masters degree with 15 years of regulatory experience, including experience in Oncology drug development and global development of products through all stages of development; or equivalent combination of education, training and experience.
• Experience providing strategic regulatory advice for the global development of products through all stages of development

PREFERRED

• Proven track record of successful interactions with regulatory authorities
• Strategic thinker with the ability to generate creative solutions to complex problems
• Strong interpersonal, communication and presentation skills
• Excellent organization and operational skills including planning, organizing and the ability to lead and influence others across all functions and levels within the organization

Additional Information

The pay range for this position at commencement of employment is expected to be between $280K and $312/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.