Senior Regulatory Affairs Manager
Andy Leake at CK Clinical is recruiting for a Senior Regulatory Affairs Manager to join an exciting UK pharmaceutical company at their site based in Cambridge on a 12-month fixed term contract. This position is salaried with a good benefits package.The Role:
Your main duties will be to:
- Be responsible for UK and Ireland specific regulatory activities relating to post-approval regulatory activities associated with the commercialised product portfolio.
- Ensure that marketing authorisations (MAs) are maintained in compliance with relevant regulatory requirements and business priorities.
- Manage the maintenance of SmPC and PIL texts in compliance with the company core datasheet and MAs, both internally and on external websites.- Provide regulatory direction and support for commercial activities.
The ideal candidate for this role will have:
- Bachelors degree or equivalent in a related scientific field.
- A proven regulatory affairs professional with a successful track record of executing effective regulatory strategy in an affiliate position, and specifically within UK and Ireland.
- Experience interacting with regulatory agencies with excellent negotiation skills and demonstrable success in influencing HA positions to ensure positive regulatory outcomes.
- Outstanding written and oral communication skills.
- Regulatory experience with Opioid/Pain products is a bonus
For more information or to apply for this position, please contact Andy Leake on 01438 842 966 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 47317 in all correspondence.