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Senior Director, Regulatory Affairs EMEA - HC Berks

£175,000 plus package - Pharma - Quality & Regulatory Affairs
Ref: 97 Date Posted: Monday 04 Feb 2019
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Purcon have the pleasure of working with a passionate, driven and fast-growing global biotech business, who have made it their mission to improve the lives of people suffering from rare and orphan diseases across the globe.

 

My client care deeply about the patients they work with and their families and strive to make the best care, medication and treatment available to each and every one of them.

 

They are currently in the process of releasing a new drug across Europe and are also setting up a new European entity in the UK/Mainland Europe. As part of this exciting expansion, they have asked Purcon to assist in on-boarding a highly knowledgeable and talented RA professional to take the senior leadership role within the new European business of Senior Director.

 

As the newly appointed Senior Director of Regulatory Affairs, EMEA you would be the most senior and key RA advisor to the business and work Globally as part of their Global RA function.

 

Reporting to the US, you would manage a small team in Europe and be responsible for providing regulatory oversight & strategic technical regulatory input to the cross-functional project teams for all project activities within the EMEA region. You would define and implement 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.

 

This is a fantastic opportunity not only to join a business that are making a genuine difference to the lives of thousands of people suffering with otherwise untreatable diseases but be a founding member of the European team. You have the ability to shape the culture and vision from the ground up.

 

So, if you are a highly experienced senior leader within RA, have worked in biotech environments and are passionate and driven to make a real difference, then please either apply online of contact Katy Wallace at kwallace@purcon.co.uk.