Our client is a global Oncology company with an impressive pipeline
- This role will lead the preparation, alignment and formulation of strategy for US and/or global regulatory submissions within our Oncology portfolio with an initial focus on a late stage BLA submission.
- This individual will lead interactions with the FDA and support/ lead interactions with global health authorities.
- The ideal candidate will have a strong understanding and experience of the Oncology space. They will also have been a global regulatory lead for multiple programs in previous roles.
- Advanced degree (e.g., Masters, Pharm.D., Ph.D.) in a scientific discipline
• Experience in the pharmaceutical industry required with 10-12 years direct regulatory affairs experience, including US regulatory experience
• Experience with ex-US regulatory authorities desirable
• Managerial experience desirable