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About the Role

The Associate Director, Regulatory Affairs supports the development and execution of clinical regulatory strategies and regulatory development activities for assigned programs across regions. This role works closely with senior regulatory leadership to develop recommendations, execute regulatory plans, prepare submissions, and support health authority interactions. The Associate Director provides regulatory guidance to cross‑functional teams and ensures regulatory deliverables are completed in accordance with applicable regulations, timelines, and internal standards.

Responsibilities

Support the development and execution of clinical regulatory strategies for assigned programs.
Plan, prepare, and manage Investigational New Drug (IND) applications and other pre‑ or post‑IND regulatory submissions.
Manage regulatory timelines, deliverables, and commitments for assigned programs.
Prepare health authority meeting materials, responses to information requests, and supporting documentation.
Participate in interactions with health authorities as part of the regulatory team.
Provide day‑to‑day clinical regulatory guidance to cross‑functional teams.
Interpret regulations, policies, and guidance documents and apply them to program activities.
Provide regulatory input into clinical development documents.
Execute regulatory activities in compliance with applicable global and regional regulations, industry guidelines, and internal policies and procedures.
Maintain inspection‑ready documentation and practices.
Proactively identify regulatory risks, issues, and gaps for assigned programs.
Develop mitigation approaches for regulatory risks, issues, and gaps.
Lead clinical regulatory execution for assigned programs on cross-functional teams.
Coordinate inputs from Clinical, Nonclinical, Biometrics, Medical Writing, CMC, and other functions.
Partner with CMC Regulatory Affairs and technical subject matter experts to ensure alignment of development and submission activities.
Monitor regulatory developments relevant to assigned programs and assess potential impacts.
Communicate regulatory development findings to regulatory leadership and program teams.
Actively contribute to the development, implementation, and continuous improvement of regulatory processes, templates, and tools.
Execute responsibilities with professionalism, integrity, and attention to detail.
Work effectively across time zones and support a collaborative team environment.

Requirements

Bachelor’s degree in life sciences with 10 years' experience in the biopharmaceutical industry of which 8 years are in regulatory affairs; or equivalent combination of education, training, and experience.
Demonstrated experience preparing and managing INDs and supporting regulatory submissions.
Experience supporting health authority interactions and cross-functional development teams.
Working knowledge of regulatory requirements and processes in major markets (U.S. and/or EU).
Strong written, verbal, and interpersonal communication skills.
Ability to work effectively in a fast‑paced, matrixed, and global environment.
Maintains the highest standards of integrity and ethics.

Skills

Regulatory Strategy
Regulatory Submissions (INDs)
Health Authority Interactions
Regulatory Guidance
Compliance
Risk Identification
Cross-Functional Collaboration
Regulatory Intelligence
Process Improvement
Communication Skills

Location

South San Francisco, CA

Work Type

Full-time

Experience Level

Associate Director
10 years experience in biopharmaceutical industry
8 years experience in regulatory affairs

Education Level

Bachelor's degree in life sciences
Advanced degree in life sciences, pharmacy, or a related field (MS, PhD, PharmD, or equivalent) - Preferred

Salary/Compensations

$198k - $257K/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.
Founded in 2014, Zai Lab 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.
Zai Lab'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.
Zai Lab became dual-primary listed on both the Nasdaq and the Hong Kong Stock Exchanges in 2022.
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.
Zai Lab is proud of the gender diversity of our company and our promotion of women in biotech.
Zai Lab has achieved gender base pay equity at all levels.
58% of Zai Lab employees are women and 54% of management positions are held by women.
Zai Lab is committed to the health of patients and our planet.
Zai Lab's environmental protection, social responsibility, and corporate governance strategy, called “Trust for Life” is integrated within its business.

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.