Similar Jobs
See allRegulatory Manager
Precision Medicine Group
US
Regulatory Affairs
Clinical Trials
Drug Development
Director, Regulatory Affairs
Recursion
UK
Regulatory Affairs
Oncology
Cross-functional Collaboration
Head of Regulatory Affairs
ARTBIO
US
Regulatory Strategy
Drug Development
FDA Regulations
Associate Director, Regulatory Affairs
Iovance Biotherapeutics
US
Regulatory Affairs
Cross-functional Leadership
Written Communication
Senior Director, Regulatory Strategy – Global Regulatory Lead
Beeline Medicines
US
Regulatory Strategy
Immunology
Project Management
Primary Function:
- Support clinical regulatory strategies under senior leadership.
- Plan and manage regulatory submissions for assigned programs.
Major Responsibilities:
- Prepare health authority meeting materials and responses.
- Provide day-to-day regulatory guidance to cross-functional teams.
- Ensure compliance with global regulations and internal standards.
Qualifications:
- Bachelor's degree in life sciences with 10+ years in biopharma regulatory affairs.
- Experience with INDs and supporting regulatory submissions preferred.
- Strong communication and collaboration skills in a global matrixed environment.
Additional Information:
- Pay range: $180k-$241k/year, plus bonus, equity, and benefits.
- Zai Lab is an equal opportunity employer committed to diversity and inclusion.
Zai Lab Limited
Zai Lab is an innovative, research-based biopharmaceutical company based in China and the US, focused on bringing transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders to patients worldwide. Founded in 2014, Zai Lab has a global team of approximately 2000 employees and is committed to gender diversity and environmental responsibility.