Our client are a global pharmaceutical business who are looking for a Senior Regulatory Affairs Officer to join their Regulatory Affairs Team Based in Hull
Responsibilities:
Efficient project management of the submission, assessment, and national approval of Market Authorisation Applications (MAA) to deliver on-time approvals for our development pipeline.
Work with change control, and compliance colleagues in Europe and India to ensure all necessary applications (variations, renewals) are filed, approved and implemented so that compliance is maintained.
Respond to requests for licence information from both internal and external customers
Contribute to the review and improvement of working practices and SOPs
Ensure departmental records are maintained and updated
Provide regulatory support and guidance to peers and less experienced colleagues
Experience Required:
Ideally, the candidate should be a graduate in pharmacy or a life science, possibly with a higher degree.
Significant experience in regulatory affairs for pharmaceutical or medical device products
Practical working knowledge of current & emerging requirements in European medicines legislation.
Knowledge of the pharmaceutical industry in Europe
Experience working with MHRA and other European Regulatory Bodies
To apply for this position, candidates must be eligible to live and work in the UK
Matchtech is acting as an Employment Business in relation to this vacancy.