Head of Regulatory Affairs

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Job description

Regulatory Affairs EAP NPP CUP Strategy Health Authority Interactions Operations

Your new company
This is a specialist services company that primarily woks with sponsors to assist physicians and patients to gain early access to medicines when there are no other treatment options available. With over 95 employees, this is a fast growing and an exhilarating company to be a part of. They have offices located in North Carolina, London United Kingdom, Portugal, and Ireland. Moreover, they possess all the essential licenses allowing them to meet drug access and distribution needs across every region, globally. Due to expansion, they are looking for a Head of Regulatory affairs.

Your new role
As Head of Regulatory affairs, you will be reporting to the Managing Director of the EU. You will be responsible for understanding, developing, and managing the regulatory strategy for Expanded Access (EAP), Compassionate Use (CUP) and Named Patient (NPP) programmes. Furthermore, you will be required to lead Regulatory strategy and operational advice to the companies' clients. Additional responsibilities will include supporting senior management and business development teams to implement the right regulatory approach. You will also be the primary point of contact for internal and external regulatory expertise.

What you'll need to succeed

* Minimum 10 years of experience in the biotech or pharmaceutical industry, and a minimum of 7 years' experience in a Regulatory capacity
* Strong experience leading client and health authority interactions
* Experience writing and reviewing regulatory documents
* Experience with regulatory strategy
* High attention to detail and excellent communication skills

What you'll get in return
You will receive a market competitive salary with annual company benefits. Moreover, you will have the option of working from home three days a week.

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.