Regulatory Labelling Consultant

Job Details

A Global Pharmaceutical company are presently looking to bring in 2 Regulatory Labelling Consultants to be based in the UK West London Office, on a contract basis.

This role involves managing the creation, review, approval and implementation of Global Data Sheets (GDSs) and Global Patient Leaflet. To provide support for labelling submissions for MRP/DCP.

Role:

- Management of the development of Global Data Sheets for assigned products/ingredients.
- Accountable for authoring patient information wording in the Global Patient Leaflet (GPL) of the GDS.
- Management of the GDS throughout the product lifecycle.
- Support of Local Operating Companies during implementation of GDS wording.
- Author responses to labelling questions.
- Participation in other projects and activities as required.
- Management of the development and maintenance of EU CP and MR/DCP labelling documents throughout the product lifecycle.

Experience:

- Life sciences degree and relevant experience.
- Demonstrated understanding of labelling regulations for medicinal products.
- Pharmaceutical labelling experience in Regulatory Affairs, including labelling preparation, leading/participating in labelling review meetings, and labelling submissions.
- Direct experience of managing labelling issues.

To Apply:

To apply, please click on the Apply button. Ideally, please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call me (Elise Lambeth) on +44 (0) 207 440 0633 or upload your CV on our website. Full description available on request.

Please note that not all of our vacancies are advertised. To register as a priority candidate, please upload your CV on our website with a short description of what you are looking for or call 0800 988 4437. We will then contact you with relevant roles: www.proclinical.co.uk. We regard all correspondence as confidential.

Proclinical is a specialist Employment Agency and Recruitment Business, providing employment opportunities within major companies in the Pharmaceutical and Biopharmaceutical industries across Europe.