Responsibilities
- To prepare submissions of license variations and applications to MHRA according to strict deadlines in co-operation with Global Regulatory Affairs (MAH).
- To prepare national submissions of such as label changes to MHRA according to strict deadlines in co-operation with Global Regulatory Affairs, marketing teams and customers such as regional QC Pharmacists.
- To provide 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, both for medicines and medical devices .
- To communicate with MHRA to resolve regulatory issues on product license variation, renewals, label changes etc. as they arise.
- To adhere to Standard Operating Procedures to describe the Regulatory Affairs activities of B. Braun UK.
- To support Global Regulatory Affairs with other projects as required.
- To participate in internal and external audits where Regulatory Affairs is involved with a view to becoming an Auditor for B Braun Medical.
- To support the medicovigilance and pharmacovigilance function within B. Braun including recording adverse drug reactions .
- To comply with Company Standard Operating Procedures and relevant legislation.
- To act as a point of contact for customers with medical information enquiries and respond to these enquiries as part of a medical information team.
- Educated to degree level (or equivalent) in Pharmacy or Biomedical Sciences.
- At least two years’ experience within Regulatory Affairs, ideally including product license variations for medicines.
- Capable of working on own initiative, under pressure in order to meet tight deadlines, ensuring attention to detail at all times.
- Ability to deal with complex projects.
JD for Requlatory Affairs Specialist Recruitment Agency in London, Pharmaceutical Recruitment Agency in London