Vice President Regulatory Affairs

The Vice President Regulatory Affairs (RA) is responsible for ensuring that compliance is being upheld for Regulatory Affairs at SAB Biotherapeutics (SAB).

This role will lead preparation, review and submission of documents to FDA and ex-US health authorities to support product development of new biologics and regulatory and compliance aspects through the drug product lifecycle.

The incumbent must be able to combine knowledge of scientific, regulatory, and business issues to ensure products are developed and manufactured according to regulations related to the manufacturing and distribution of biologics.

This position manages and prioritizes RA team work on all required interim and final BLA and MAA submissions.

The incumbent will regularly work cross-functionally with Clinical Development/Pharmacovigilance, Manufacturing/CMC, Quality, Medical Affairs and Commercial Readiness teams to ensure regulatory objectives align with corporate strategy...

Ready to Apply?

Submit your application today and join our talented team at SAB.