Associate Director, Regulatory Affairs

Zai Lab

. Support development and execution of clinical regulatory strategies for assigned programs .

Posted 9/15/2026full-timeRemote • California • United StatesSenior💰 $180,000 - $241,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Expertise in clinical regulatory strategies, IND application management, and compliance with global regulations is essential. Strong communication and collaboration skills are necessary for effective cross-functional team support and health authority interactions.

Highest-signal resume keywords

Clinical Regulatory Strategy DevelopmentIND Application ManagementHealth Authority Interaction SupportRegulatory Compliance KnowledgeCross-Functional Team Collaboration

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory AnalysisIND Submission PreparationRegulatory Risk IdentificationRegulatory Documentation ManagementRegulatory Process Development

Soft Skills

Strong Written CommunicationInterpersonal CommunicationAbility to Work in Fast-Paced Environments

Industry Keywords

Biopharmaceutical IndustryRegulatory AffairsGlobal RegulationsU.S. Regulatory RequirementsEU Regulatory Requirements

About the role

Key responsibilities & impact

Support development and execution of clinical regulatory strategies for assigned programs
Contribute regulatory analyses, options, and recommendations
Plan, prepare, and manage IND applications and other pre- or post-IND submissions
Manage regulatory timelines, deliverables, and commitments with cross-functional teams
Prepare health authority meeting materials, responses to information requests, and supporting documentation
Participate in health authority interactions
Provide clinical regulatory guidance to cross-functional teams
Provide regulatory input into protocols, Investigator’s Brochures, and study reports
Execute regulatory activities in compliance with global and regional regulations, industry guidelines, and internal policies
Maintain inspection-ready documentation and practices
Identify regulatory risks, issues, and gaps and develop mitigation approaches
Lead clinical regulatory execution 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
Monitor regulatory developments and assess potential impacts
Contribute to regulatory processes, templates, and tools

Requirements

What you’ll need

Bachelor’s degree in life sciences with 10 years' experience in the biopharmaceutical industry, including 8 years 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

Benefits

Comp & perks

Sign-on bonus
Restricted stock units
Discretionary awards
Medical benefits
Financial benefits
401(k) eligibility
Paid vacation
Paid sick time
Paid parental leave
At-will employment