Senior Regulatory Affairs Manager
Proclinical has partnered with a global pharmaceutical organisation in search for a Senior Regulatory Affairs Manager. This role is to ensure that marketing authorisations are obtained and are in line with the company's values and goals
- Prepare or manage the preparation of marketing authorisation applications under supervision
- Prepare efficiently and submit responses to enquiries and deficiencies noted by regulatory authorities in connection with applications filed, under supervision, to facilitate the earliest possible approval.
- For Centralised Applications, ensure that Global Business Units are informed of status of applications and artwork is developed to support product launche
- Prepare and submit, according to agreed timelines, the necessary documentation to the regulatory authorities to maintain and update existing marketing authorisations, under supervision, to ensure continued development of existing products.
- Review labelling, pack leaflets and summary of product characteristics etc. to ensure compliance with current legislation and registered particulars and act, as agreed with supervisor, to secure regulatory approval where necessary
Skills and Requirements
- Life sciences or chemistry degree with proven relevant experience within regulatory in the pharmaceutical industry (country affiliate role for UK & Ireland
- Comprehensive understanding of licencing processes for marketing authorisations, particularly via the EU Centralised Procedure, and submission to regulatory authorities
In case you have difficulty in applying or if you have any questions, please contact Peter Duvall on 44 203 0789 542 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.