(Senior) Manager, Regulatory Affairs

Hays Life Sciences is exclusively retained by a growing biopharmaceutical company to assist in their search for a (Senior) Manager, Regulatory Affairs to be based in New York.

This is a clinical stage company with numerous promising product candidates in development from phase I through III and are working towards filing multiple NDAs later this year.

They are seeking a seasoned Regulatory professional to join the Regulatory Affairs team in a highly important and visible role.

In this capacity, you will support the development, authoring and review of regulatory submissions such as NDAs, MAAs, INDs, TGAs and CTAs.

You will participate in regulatory strategy development and planning as well as regulatory agency interactions.

In addition, you will participate in risk assessments, regulatory inspection readiness activities and help prepare for agency meetings and communications.

At minimum, you must possess a Bachelor’s degree in a scientific discipline, 5 years of Regulatory Affairs experience in the pharmaceutical industry, NDA submissions experience and eCTD submissions experience.

Experience with MAA submissions, hands-on experience in authoring regulatory submissions and a CNS background are all bonuses.

Apply now for consideration.