Remote Associate Director, Regulatory Affairs

SmartRecruiters, Inc.; South San Francisco (CA); Remote; USD 180,000 - 241,000; Full time

Benefits offered by this job

Sign-on bonus

Restricted stock units

Discretionary awards

Medical benefits

401(k) eligibility

Paid time off

Job summary

Zai Lab Limited is seeking an Associate Director, Regulatory Affairs to lead regulatory strategy and execution for global programs. This remote role reports to the VP, Regulatory Affairs and collaborates with Clinical, Nonclinical, Biometrics, Medical Writing, CMC, and other teams to ensure timely submissions and compliant documentation.

The ideal candidate has 10+ years in biopharma regulatory affairs, experience with INDs, and strong interaction with health authorities across major markets.

Qualifications

• Bachelor’s degree in life sciences with 10 years in biopharma, 8+ years in regulatory affairs.
• Advanced degree preferred (MS/PhD/PharmD or equivalent).
• Experience preparing/managing INDs and regulatory submissions.
• Experience supporting health authority interactions and cross‑functional teams.
• Strong written, verbal, interpersonal communication; global environment experience.

Responsibilities

• Regulatory Strategy: develop and execute clinical regulatory strategies for assigned programs.
• Regulatory Submissions: plan, prepare, and manage INDs and other submissions; ensure content quality and timeliness.
• Health Authority Interactions: prepare meeting materials and participate in interactions.
• Regulatory Guidance: provide day‑to‑day guidance to cross‑functional teams on regulations and policies.
• Compliance: ensure activities align with global regulations and internal policies; maintain inspection‑readiness.
• Risk Identification: flag regulatory risks and propose mitigation.
• Cross‑Functional Collaboration: lead regulatory execution with Clinical, Nonclinical, Biostatistics, Writing, CMC, and other functions.
• Regulatory Intelligence: monitor developments and communicate impacts to teams.
• Process Improvement: contribute to templates, tools, and processes to improve efficiency.
• Professional Conduct: maintain integrity and collaboration across time zones.

Skills

Regulatory strategy

IND submissions

Health authority

Cross-functional

Regulatory guidance

Education

Bachelor's degree in life sciences

Advanced degree (MS/PhD/PharmD)

Job description

Zai Lab Limited is seeking an Associate Director, Regulatory Affairs to lead regulatory strategy and execution for global programs. This remote role reports to the VP, Regulatory Affairs and collaborates with Clinical, Nonclinical, Biometrics, Medical Writing, CMC, and other teams to ensure timely submissions and compliant documentation.

The ideal candidate has 10+ years in biopharma regulatory affairs, experience with INDs, and strong interaction with health authorities across major markets.