Regulatory Affairs Specialist, Neurology

Salary & Benefits
Competitive
Employment Type
Full Time, Permanent
Department
Neurology, Regulatory Affairs
Report to Position
Senior Director, Neurology Regulatory Affairs
Location
EMEA Knowledge Centre, Hatfield, Hertfordshire
Business Area
Application Deadline
29 March 2019

Full Job Description

Your new role

We are currently looking for an individual to join our Neurology Regulatory Affairs Team, providing regulatory support to Eisai's Epilepsy & Alzheimer's portfolio. We are flexible on level within the team so open to considering individuals at Manager, Senior Manager or Associate Director level who has an interest in joining Eisai's exciting Regulatory group.

Within this role you will be involved in submission work (including preparation of orphan drug applications, PIPs and Clinical Trial applications) as well as providing input into Global Regulatory strategy and the design of Clinical development programmes. There may also be some post approval work of centralised products within the role.

 

What are we looking for?

You will have a demonstrated background in a Regulatory Affairs function gained within the Pharmaceutical industry. Specific experience in a neurology therapy area would advantageous but not essential.

You should have proven experience with EU regulatory processes including clinical trials, scientific advice, PIPs and orphan drugs. Regulatory strategy experience and/or experience liaising with regulatory authorities is advanatageous.

 

What we offer in return

Eisai offers a competitive salary and excellent wider benefits package.

 

You will also be based from our excellent Knowledge Centre facility, which provides a great, collaborative working environment coupled with a campus feel including facilities such as restaurant, coffee shop and dry cleaning services.

 

What you need to do next

If you are interested in this position, please click the ‘click here to apply’ at the bottom or top of this advert. On submitting an application please include a copy of your CV for review. On applying, you will be asked for your current salary / package details, your notice period and your current location - applications without this information may not be considered.

 

If you have any questions, please contact us on recruitment@eisai.net.

 

We aim to respond to all successful applications as soon as possible. However please note unfortunately due to the volume of applications received we are unable to respond to unsuccessful applications.