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. ...
Requirements: 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.
