Senior Manager, Regulatory Affairs
CK Group are recruiting for a Senior Manager, Regulatory Affairs to join a global pharmaceutical company in Uxbridge on a permanent basis.
The Role: To provide regulatory guidance and support and execute regulatory activities in UK and Ireland for assigned marketed products and development projects.
- Develop regulatory strategies and advice and provide clear guidance and information to internal and external stakeholders.
- Provide and prepare national informationand documents for submission including documents.
- Lead interactions with MHRA and HPRA.
- Keep current with, review and interpret regulatory and scientific regulations, directives, guidelines and initiatives.
- At least a University degree in a scientific discipline.
- Extensive Regulatory experience gained within pharmaceutical companies with an emphasis on regulatory pre-submission and post-approval activities and preparation of new marketing authorization in Europeand UK.
- Deep knowledge of European and national laws, regulations, guidelines and other requirements.
- Understanding of development and life-cycle management of drugs and regulatory processes.
- Oncology experience preferred.
Apply: Entitlement to work in the UK is essential. For more information or to apply for this position, please contact Andy Leake by phone on 01438 842 966 or email on email@example.com. Please quote reference 49692 in all correspondence.