Yorkshire, United Kingdom
about 2 years ago
We are looking for a highly focused individual to work with Global Regulatory Affairs and Head of Regulatory Affairs UK, following Standard Operating Procedures (SOPs), to ensure that the Company's products comply with the regulations of the Medicines and Healthcare products Regulatory Agency (MHRA). You will also be responsible to further develop the Regulatory Affairs role to comply with the changing regulatory environment post BREXIT.
Preparing submissions of license variations and renewals to MHRA according to strict deadlines in co-operation with Global Regulatory Affairs.
Preparing submissions of label changes to MHRA according to strict deadlines in co-operation with Global Regulatory Affairs, Marketing teams and customers such as regional QC Pharmacists.
Providing an accurate, timely and balanced Regulatory Affairs service to all departments within B. Braun UK taking responsibility for answering technical and regulatory enquiries from colleagues to support their business activities.
Communicating with MHRA to resolve regulatory issues on product license variation, renewals, label changes etc. as they arise.
Establishing and maintaining an accurate filing system for Regulatory Affairs activities within each division and for each product as required.
Supporting Global Regulatory Affairs with other projects as required.
Participating in internal and external audits where Regulatory Affairs is involved.
Supporting the medicovigilance and pharmacovigilance function within B. Braun.
Deputise for the Regulatory and Quality Manager as required.
What you'll need to succeed:
Be educated to degree level (or equivalent) in Pharmacy or Life Sciences.
Have experience within the pharmaceutical/ medical device industry and specific experience of Regulatory Affairs.
Be capable of working on own initiative, under pressure in order to meet tight deadlines, ensuring attention to detail at all times.
Have the ability to deal with complex projects.
Our team deserve great benefits
Aside from offering a competitive salary, we have tailored our benefits package to make it relevant for your role with the aim to support you at work and at home. This includes group pension plan, life assurance, private medical insurance, enhanced annual leave, enhanced statutory pay and group income protection to name a few.