full time legal management

Job Details

Hays Life Sciences is currently partnered with a leading global contract research organization (CRO) to assist them in their search for a remote-based Global Regulatory Affairs Director. This company is one of the top CRO's in the world and manages projects for many of the top pharmaceutical organizations in the market. As this is a strategic regulatory position, this individual will work in a highly visible capacity and as such, this is a very important addition to the team.

In this capacity, you will provide strategic direction on regulatory projects, plan and lead activities associated with FDA meetings, and act as a point of contact for regulatory agencies for assets. You will coordinate key messages for product/portfolio specific regulatory documents to be submitted to regulatory authorities. In addition, you will provide input into asset specific regulatory strategy on a global scale.

At minimum, you must possess a Bachelor’s degree in a scientific discipline, 8+ years of... Regulatory Affairs pharmaceutical/CRO industry experience, deep regulatory strategy expertise and clinical regulatory experience. You must be based in the United States, ideally on the East Coast.

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