A well-established biotechnology research organization is looking to add a Manager as a key contributor to the development of their biologic portfolio. This position is also offered at the Senior Manager level for the right candidate.
The Regulatory Manager/Senior Manager 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 Regulatory Manager/Senior Manager should have:
- 6-10 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.