about 1 month ago
Job title: Regulatory Affairs Officer UK/IE
A Pharmaceutical company in Essex are seeking a Regulatory Affairs Officer. This role will focus on post-approval changes for a range of products within the UK/IE portfolio.
- Prepare, compile, review and submit appropriate high quality regulatory dossiers, post-approval changes (variations, renewals, PIQU submissions) and responses to Health Authority questions
- Perform the necessary regulatory tasks to help obtain new Marketing Authorisations and maintain the existing licence portfolio in the UK/IE.
- Ensure approvals are secured within the stipulated timelines for designated projects.
- Maintain and develop awareness of current/pending regulatory legislation and guidelines
- Degree in life sciences/pharmacy or equivalent qualification
- experience in the Pharmaceutical Industry, ideally within Regulatory Affairs, but experience in R&D, Quality or Operations also taken into consideration
- Desirable to have UK, IE or other EU member state experience and knowledge of regulatory procedures
Salary and benefits:
A highly competitive salary, annual bonus, private medical insurance and wider benefits package is on offer.
To apply for this position or hear further details then please contact Matt Thomas via email@example.com