Regulatory Affairs Officer - EU Submissions
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 equivalentFor further details about this role, or other opportunities within Regulatory Affairs, please contact Tim Barratt on +44(0)1727 817 626 or email email@example.com.