I am delighted to be representing a pioneering Biotech client who specialise in bringing life-changing therapeutics to children and adults suffering with rare, orphan diseases.
My client, after successfully gaining FDA approval for a breakthrough product, are now expanding their commercial entity to the EMEA region and are in the process of establishing their European Head Office.
I am currently assisting them with hiring a seasoned, experienced Senior Director to take full responsibility for Regulatory Affairs across EMEA. Initially, the role will be home-based while the Head Office is set up - likely the office will be in Home Counties, UK.
In this newly created role, you would be fully responsible for defining and implementing global regulatory strategies; ensuring that all regulatory requirements/commitments are met with respect to regulatory submissions for INDs, IMPDs, MAAs, NDAs and other regional submissions.
Your key responsibilities would be;
To be successful in this role you will need the following;
My Client are passionate about their mission to transform the lives of their patients. They are developing novel, targeted therapies to help serve the critical unmet needs of their patients. They care deeply about their ability to improve not only the therapies received, but also improving the entire patient experience, from diagnosis and treatment to everyday living.
This is a fantastic opportunity to be part of the early stage establishment of the European Operation in a crucial and highly influential role.
If you are interested and want more information, please apply or contact Katy Wallace at firstname.lastname@example.org
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