Fantastic opportunity for an experienced Regulatory Affairs Manager to join a top ten pharmaceutical company for a 6- month contract. This role will be fully remote with occasional trips to their offices in London.
As Regulatory Affairs Manager you will provide effective regulatory support to the UK and global organisations for maintenance of assigned Marketing Authorisations (MAs) whilst developing knowledge of all aspects of life- cycle management. You will work closely with global and local colleagues to advise and agree on regulatory strategy and data requirements. The role will involve you critically evaluating submission packages inline with regulatory requirements in order to eliminate deficiencies prior to construction and submission of MA applications. You will also drive negotiations with MHRA to ensure best possible outcome, as well as provide regulatory advice to global and UK business on all aspects of maintenance work.
The successful candidate will be educated to degree level within the life sciences and have broad relevant regulatory work in the pharmaceutical industry. It is essential that you have MHRA Submission experience.
Keywords: Regulatory Affairs Consultant, Regulatory Affairs Specialist, Regulatory Affairs Associate, Regulatory Affairs Manager, Pharma, Pharmaceuticals, MHRA, Marketing Authorisations, London, South East, Remote, Home- Based, Contract, Temp, Temporary, Regulatory Affairs.