Regulatory Affairs Manager
Proclinical has partnered with a global pharmaceutical organisation in search for a Regulatory Affairs Manager. The Berkshire based role will focus on Life-cycle management including variations and renewals.
- Manage the regulatory support for the launch of new products and lifecycle management of the existing portfolio.
- Manage the review, preparation, submission and follow-up of regulatory submissions to the UK and / or Irish regulatory authorities, to high standards, to ensure that marketing authorisations are obtained and maintained in line with the company's plans and goals.
- Oversee regulatory strategy for new marketing authorisation and continued ongoing maintenance activities
Skills and Requirements
- Proven success in achieving regulatory approvals in the UK and /or Ireland
- Significant post-licencing experience with an in-depth working knowledge of lifecycle maintenance for pharmaceutical products, including variations and renewals
- Strong leadership capabilities with a record of proven success in managing and supervising staff
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.