Regulatory Affairs Manager - EU

Competitive Salary
22 Oct 2018
19 Nov 2018
Georgia Walden
Contract Type
Full Time
An exciting opportunity for an experienced Regulatory Affairs Manager in EU Strategy has become available within a leading Global Pharmaceutical company, specialising in both Small and Large molecules, based in the Buckinghamshire area. As the Regulatory Affairs Manager - EU you will be responsible for leading a range of product focused projects. You will manage products that are at early development and clinical stage as well as the life cycle management of established products.


Your duties as the Regulatory Affairs Manager - EU will be varied however the key duties and responsibilities are as follows:

1. Manage a range of products currently at clinical trial. You will agree future strategy and ensure the regulations are in place and up-held through out the trial. You will also have the opportunity to work on products at early stage development where Scientific Advise may need to be obtained.

2. You will sit within the EMEA team and will focus on products marketed in the EU under a range of procedures including Centralised - CP, Decentralised - DCP and Mutual Recognition - MRP.

3. The life cycle management of existing licenses including Variations, Renewals and PSUR's.

4. You will offer strategic advise for Marketing Authorisation Applications - MAA and use your expertise and knowledge with Regulatory Agencies to ensure the successful approval on novel licenses.


To be successful in your application to this exciting opportunity as the Regulatory Affairs Manager - EU we are looking to identify the following on your profile and past history:

1. Relevant degree in a Life Sciences discipline (e.g. Biology, Chemistry, Pharmacology etc.) in addition to extensive experience within a Regulatory Affairs setting

2. Proven Regulatory Affairs experience with Drug Development, including but not limited to Clinical Trial experience and Non-Clinical experience. You can have experience across a range of product types but knowledge of Ophthalmology and GI products (Both small and large molecules) will be beneficial to your application.

3. A working knowledge and practical experience with either CP, DCP and MRP is important for your application. Experience with Regulatory Strategy will be vital for this role.

Key Words: Regulatory Affairs | Manager | Senior Manager | Strategy | Clinical Trials | Life Cycle Maintenance | MAA | CP | DCP | MRP | EU | EMEA | Variations | Renewals

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.