Regulatory Affairs Officer

Key People Limited
West Midlands Region
30000.00 - 35000.00 GBP Annual + + bonus and benefits
10 Aug 2017
18 Aug 2017
Contract Type
An excellent opportunity has arisen for a Regulatory Officer with 1-3 years of experience to join a leading Pharmaceutical company based in East Anglia.

Main Responsibilities:

- To manage post approval activities on a defined group of nationally approved products
- Review, compile and submit high quality regulatory submission packages to the UK MHRA and other EU Regulatory agencies where applicable.
- To work closely with manufacturing, QA, packaging testing, artwork origination and release sites, plus Medical and Pharmacovigilance departments, in order to support the preparation, compilation, review and submission of high quality regulatory documentation in accordance with UK requirements, legislation, guidance, and company procedures.
- To work closely with EU RA Competence Centres in order to provide timely UK specific documentation and/or information in support of EU new submissions and/or variations and renewals.
- To identify, initiate and prioritise areas for process improvement, and manage change as required.
- To ensure that all activities fully comply with Departmental and Company SOPs & Work Instructions.
- To ensure that all internal tracking tools and electronic databases are maintained, accurate and complete.
- To represent UK Regulatory Affairs in cross functional teams
- To understand and communicate complex issues to other Regulatory, Quality, Supply Chain, Product Management Medical, Pharmacovigilance, EPD and Senior Management colleagues.

Experience Required:
To be considered for these regulatory positions you should be educated to degree level in Life Sciences (or equivalent) along with significant experience within EU or UK Regulatory Affairs. You should have a good standard of technical knowledge, whilst CMC experience is desirable.