Regulatory Affairs Manager
A pharmaceutical company specialising in the neurology market is currently looking for a Regulatory Affair Manager in South East England. This is an excellent opportunity to work for a global leader in the neurology industry.
- Prepares, submits and coordinates national Marketing Authorisation Applications in accordance with local, EU, and global submission requirements.
- Ensures submissions are made in agreed timeframe and in line with current health authority regulations to support department schedules/priorities for launch and maintenance.
- Updates relevant functional stakeholders of any delays and/or schedule conflicts in fulfilling regulatory plans.
- Liaises with Artwork Coordinator regarding preparation/approval of mock-ups
- Compiles and submits renewals (where relevant) prior to MA expiry in line with the variation regulation, SOPs (where relevant) and national Competent Authority requirements
- Monitors timelines for generating/submitting new launches, renewals and variations documentation on a monthly basis
- Update and maintain the regulatory databases as needed (Register, Team Trackers, and Docubridge)
- Maintains, in an up-to-date fashion, the Company's Manufacturer's / Importer's Authorisations and Wholesale Dealers Licences
Skills and Experience
- Significant Regulatory Affairs experience of handling complex licences in terms of full submissions and maintenance
- Knowledge of EU and Global Regulatory requirements
- Experience in dealing with the Health Authorities
- Experience in dealing with multiple partners and affiliates
- Degree in Life Sciences
Please click on the Apply button. 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 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.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies