Based within Quality Operations and reporting to the Industrial Regulatory Affairs Manager, you will have responsibility for providing regulatory support – internally for specified site and product compliance activities, and externally for client regulatory projects and regulatory services such as CTD quality writing (primarily for variations and post-approval changes).

The wide variety of dosage forms developed and manufactured on site will provide you with the opportunity to broaden your regulatory skills within initial applications (NDA/MAA) and through early stage development (IND/IMPD).

At least 3 years Regulatory Affairs experience gained in the pharmaceutical or biotechnology industries is required.  Previous MHRA exposure would be an advantage.  Degree qualified in a scientific discipline, you will be an excellent communicator, both in writing and orally, in order to interface across functions.  You should be able to prioritise your workload effectively and carry out all tasks in a meticulous and accurate manner.