Zai Lab · 2 weeks ago
Director, Regulatory Affairs (Office based - 3x/week)
South San Francisco, CA
Full-time
Hybrid
Director/Executive
$221K/yr - $246K/yr
12+ years expZai Lab is a patient-focused, innovative, commercial-stage, global biopharmaceutical company dedicated to discovering and developing therapies for significant medical conditions. The Director of Regulatory Affairs will lead the development and execution of regulatory strategies for assigned assets, ensuring compliance and effective communication with health authorities.
BiotechnologyHealth CarePharmaceutical
Responsibilities
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%
Qualification
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
Benefits
Sign-on bonus
Restricted stock units
Discretionary awards
Full range of medical, financial, and/or other benefits
401(k) eligibility
Various paid time off benefits, such as vacation, sick time, and parental leave
Company
Zai Lab
Zai Lab brings transformative medicines for cancer, autoimmune, and infectious diseases to patients in China and around the world.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
$2.28BKey Investors
OrbiMedAdvantech CapitalQiming Venture Partners
2025-10-16Post Ipo Debt· $42.1M
2024-11-14Post Ipo Equity· $230M
2021-04-19Post Ipo Equity· $857.5M
Leadership Team
Yajing Chen, PhD
Chief Financial Officer
Ann Beasley
Chief Compliance Officer
Recent News
Company data provided by crunchbase