A well-established biotechnology research organization is looking to add an Associate Director to heavily contribute to the development of their biologic portfolio.
The Associate Director Regulatory Affairs will be responsible for:
- Liaising with with Health Authorities (primarily US FDA)
- Leading full life-cycle of Regulatory submissions, most importantly BLA
- Being an integral cross-functional team member and representative of the Regulatory function
The Associate Director Regulatory Affairs should have:
- 10-12 years of Regulatory experience in the pharmaceutical industry
- A background of hands-on work with biologic products- specifically BLA phase
- Extensive FDA submissions and audit experience
If you are interested in learning more about this position, please apply here.