Regulatory Affairs: Associate Director, Global Submissions

Zai Lab, Ltd.; Tulsa (OK); Remote; USD 180,000 - 241,000; Full time

Job summary

Zai Lab is seeking an Associate Director, Regulatory Affairs to lead regulatory strategy and execution for clinical programs. The role collaborates with senior leadership and cross‑functional teams to prepare INDs and submissions, respond to health authorities, and ensure compliance across regions.

The position reports to the VP, Regulatory Affairs and is based remote. This senior regulatory role requires a life sciences degree with extensive regulatory experience, strong communication skills,

Qualifications

• Bachelor’s degree in life sciences with 10 years’ experience in the biopharmaceutical industry of which 8 years are in regulatory affairs
• Advanced degree in life sciences, pharmacy, or a related field (MS, PhD, PharmD, or equivalent) preferred.
• 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.

Responsibilities

• Support development and execution of clinical regulatory strategies under senior leadership.
• Plan, prepare, and manage INDs and other regulatory submissions; ensure timely delivery.
• Prepare health authority meeting materials and responses; participate in interactions.
• Provide day-to-day regulatory guidance to cross-functional teams.
• Execute regulatory activities in compliance with global regulations and internal policies.
• Identify regulatory risks and develop mitigation approaches.
• Lead cross-functional clinical regulatory execution and coordinate inputs from multiple functions.
• Monitor regulatory developments and communicate implications to teams.
• Contribute to process improvements of regulatory templates and tools.

Skills

Regulatory strategy

IND submissions

Cross-functional collaboration

Regulatory guidance

Global regulatory knowledge

Education

Bachelor's degree in life sciences

Advanced degree in life sciences/pharmacy or related field

Job description

Zai Lab is seeking an Associate Director, Regulatory Affairs to lead regulatory strategy and execution for clinical programs. The role collaborates with senior leadership and cross‑functional teams to prepare INDs and submissions, respond to health authorities, and ensure compliance across regions.

The position reports to the VP, Regulatory Affairs and is based remote. This senior regulatory role requires a life sciences degree with extensive regulatory experience, strong communication skills,