Job Title: (Senior) Regulatory Officer - South East
Job Summary:
Key People are currently working with a leading pharmaceutical company to offer an experienced regulatory professional the opportunity to join their UK team at Regulatory Officer/Senior Regulatory Officer level.
Key Responsibilities:
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.
Qualifications/Experience:
* Extensive experience of working in a regulatory environment (minimum 2 years)
* 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
For more information please contact:
Adam Griffin
agriffin@keypeople.co.uk
+44 1727 817 648
"Regulatory Affairs" "Regulatory Officer" "Regulatory Affairs Officer" "Pharmaceuticals" "ABPI" "UK" "South East"