MAIN RESPONSIBILITIES:
- Gain marketing authorisations for new pharmaceutical products in the UK
- Maintain marketing authorisations as required.
- Liaise with European Regulatory Affairs and Corporate groups on regulatory issues.
- Liaise with external regulatory authorities as required.
- Draft of packaging texts, SmPCs, PILs and Prescribing Information.
- Review of promotional material in accordance with The Prescription Medicines Code of Practice Authority (PMCPA)/ABPI Code
- Liaise and attend meetings with other company functions to provide regulatory advice for new products.
- Maintain awareness of current and new legislation/guidance and ensure that work is in compliance with the statutory requirements.
ACCOUNTABILITY:
-Responsible for presentation and accuracy of all prepared documentation.
-A moderate level of supervision is required for this role. The position demands that the person is able to recognise the -potential impact of emerging issues and highlight these to their line manager.
-Accountable to Regulatory Affairs Manager
-Compliance & Regulatory Affairs
-Established Products Division
BACKGROUND:
- Extensive experience of working in a regulatory environment
-Good communication skills, both verbal and written
-The ability to thrive in a changing environment and to re-prioritise workload to meet business needs.
-Good project management skills