Description
Regulatory Affairs OfficerMy client is a leading company in the medical devices and pharma sector and they are currently hiring for two regulatory affairs people to join their expanding team in their pharma division based in Westmeath.
Experience required:
Regulatory experience in a pharmaceutical industry of 2-5 years is essential.
EU submission experience essential for 1 of the Regulatory Affairs Officer role
QC background would be an advantage for the other Regulatory Affairs Officer role
The ideal candidate will be educated to at least a degree level in a scientific discipline
Reliability, IT literacy, excellent organisation skills and the ability to plan and complete projects to set timelines is essential
The ability to communicate effectively with people at all levels, both verbally and in writing.
The role will involve:
Submission of licence applications, variations and renewals worldwide
Ensure that all new licence and variation applications are planned, tracked and obtained in a timely manner
Ensure all operations are fully compliant with licence details and updated in accordance with relevant guidelines and directives
Review of internal documentation to ensure compliance with licence details and relevant guidelines and directives
Identify and implement practices to reduce regulatory approval timelines
Liaise with other departments to ensure correct supporting data generated and provided in a timely manner
If you are interested in this regulatory affairs officer position please contact me on for more information and for immediate consideration. This is a permanent role based in Westmeath.
To find out more about Real please visit www.realstaffing.com