Associate Director, Regulatory Affairs
LonzaGuangzhou City, Guangdong, China
Posted February 11, 2026
Full Time
About the Company
Lonza is a global leader in the development and manufacturing of biologics and small molecule active pharmaceutical ingredients.
Job Description
Lead the development and execution of regulatory strategies for China, ensuring compliance with NMPA and Local HA regulations and alignment with ADS and global RA objectives. Provide expert regulatory guidance to the Nansha site and cross-functional teams to support product development, tech transfers, manufacturing changes, and lifecycle management.
Requirements
- Degree in Life Sciences
- 10+ years of experience in industry
- Expertise in Chinese regulatory requirements
- CMC expertise
- Established contacts with Health Authorities in China
- Good understanding of biologicals, specifically mammalian fermentation
- Experience in participating in Domestic and International Regulatory interactions
- Demonstrated project management skills
- Excellent organizational and communication skills
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Visa Sponsorship
- Four Day Work Week
- Generous Parental Leave
- Tuition Reimbursement
- Relocation Assistance
