Head of Regulatory Affairs
- Shanghai, China
About the Role
The role involves developing global registration strategies for Ailux innovative pipelines ,planning of submission pathways in China, the US, and the EU.
Responsibilities
- Lead and review the IND/NDA/BLA submission dossiers to ensure compliance with FDA/EMA/NMPA technical requirements.
- Establish cross-functional collaboration mechanisms for regulatory affairs.
- Coordinate an average of 20+ regulatory authority meetings annually.
- Monitor changes in ICH/GCP/GMP regulations.
- Issue policy impact analysis reports on a quarterly basis.
Qualifications
- Master’s degree in Pharmacy, Bioscience, or a related field.
- At least 8 years of experience in innovative drug regulatory submissions.
Required Skills
- Proficient in FDA 21 CFR, EMA Guidelines, and NMPA technical guidelines.
- Led and completed at least 3 innovative drug dual submissions (China and US).
- CET-6 or equivalent English proficiency.
- Capable of drafting professional regulatory documents and participating in technical defense meetings.
Preferred Skills
- Experience in cross-functional team leadership.
- Strong analytical and problem-solving skills.
Pay Range and Compensation Package
Competitive salary based on experience and qualifications.
Equal Opportunity Statement
Ailux is committed to diversity and inclusivity in the workplace. We encourage applications from individuals of all backgrounds and experiences.