Regulatory Affairs Officer

REGULATORY AFFAIRS OFFICER, C£40000 + Good Benefits, Andover, Southampton.

The Role: REGULATORY AFFAIRS OFFICER: To provide Regulatory advice and support to the UK Companies Affiate.

REGULAROTY AFFAIRS OFFICER: KEY 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.
* Responsible for presentation and accuracy of all prepared documentation.

REGULATORY AFFAIRS OFFICER:Skills / Experience / Qualifications : Regulatory Affairs Officer:
* Degree in Life Sciences / Equivalent experience
* Extensive experience of working in a regulatory environment
* Good project management skills
* Man-management experience