Regulatory Affairs Submission Coordinator/Senior Associate

Din browser (Safari 1.0) er mere end 3 år gammel.

Vi anbefaler at du opgraderer til den nyeste version, da vi ellers ikke kan garantere at alt funktionalitet på Jobindex vil fungere korrekt.

The job ad has expired!

Go to the ad to see if the company is still willing to receive applications.

Regulatory Affairs Submission Coordinator/Senior Associate

Hørsholm

See travel time

Y-mAbs Therapeutics A/S (Y-mAbs) is expanding and is now looking for an experienced Regulatory Submission Coordinator in a newly established position.

Y-mAbs is facing an exciting time planning for BLA and MAA submissions, as well as initiating clinical development for new projects.

Key responsibilities:

Coordinate and support regulatory submissions such as clinical trial applications and amendments, IND submissions and amendments, BLA submissions, and MAA submissions in collaboration with our CROs
Tracking health authority correspondence together with our CROs
Keeping the Regulatory Overviews up to date