Regulatory Affairs Officer - EU Submissions

Recruiter
Key People Ltd
Location
London
Salary
£30000 - £35000 per annum + benefits
Posted
17 Jun 2017
Closes
17 Jul 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
An excellent opportunity has arisen for an experienced Regulatory Affairs Officer to join the EU team at one of the largest pharmaceutical companies in the world. Within this role you will be responsible for registrations and life cycle maintenance across Europe and will have the opportunity to progress your career and take on more responsibility as your experience grows.

To be considered for this role you will be educated to BSc (Hons) level (or equivalent) and ideally have knowledge of regulatory affairs and the pharmaceutical industry, ideally with good knowledge of EU regulatory procedures and requirements. Excellent verbal and written skills are essential as communication will play a key part in this in this role.

Main Responsibilities:

-Submission of new generic Marketing Authorisation Applications for a wide variety of products. Doseage forms will include; tablets, modified release capsules, injectables and oral solutions. These are registered through Centralised, Decentralised or Mutual Recognition Procedure.
-You will work closely with your manager and the R&D sites to support the preparation, compilation, review and submission of high quality regulatory dossiers
-Post marketing documentation maintenance and submission in accordance with EU requirements.
-You will also support regulatory submissions from development through to first launch, taking an active role in the project team.

Experience:

-You will ideally have previous EU exposure and have 1-3 years of regulatory experience
-MRP/DCP submission experience, end to end.
-Ideally previous generics experience
-Strong communication skills
-BSc (Hons) or equivalent

For further details about this role, or other opportunities within Regulatory Affairs, please contact Tim Barratt on +44(0)