An international biotechnology company focused on developing drugs, especially for cancer treatment. With a global huge team with thousands of employees across five continents. They are now looking for a Regulatory CMC Associate Director/Director in Japan.
This opportunity provides amazing growth potential, career progression, and the chance to be working with a growing company.
- Manages both small molecule and biologics products.
- In collaboration with global project regulatory CMC teams, develop and implement Japan CMC-related regulatory submission strategies and timeline; work collaboratively with cross-functional teams and communicate Japan strategies and timeline as needed.
- Conduct regulatory risk assessment, and identify key CMC regulatory issues and mitigation activities on Japan regulatory submissions.
- 7-10 years of related pharmaceutical or biopharmaceutical industry regulatory CMC experience.
- Educational background in scientific disciplines and expertise in at least one area in pharmaceutical development (chemical process, formulation, manufacturing, QC, QA, etc)
- Good communication skills and team spirit
- Business English
If you are interested, please apply with your CV attached.