Description
My client, a leading pharmaceutical company, is urgently recruiting a Regulatory Affairs Officer to join their expanding team in Dublin. The successful candidate will work on the submission of license applications, variations and renewals and ensure that all new license and variation applications are planned, tracked and obtained in a timely manner.The Regulatory Affairs Officer job will involve:
* Ensure that all new license and variation applications are planned, tracked and obtained in a timely manner in accordance with various EU submission procedures.
* Preparation and submission of license and variations to the HPRA, MHRA and other Regulatory Authorities as required.
* Liaise directly with the regulatory authorities in order to ensure timely approvals and speedy resolution of any issues.
* Ensure all operations are fully compliant with license details and updated in accordance with relevant guidelines and directives.
* Ensure up to date files are maintained for all licensed products manufactured and/or released at their site.
* Review of relevant reports to ensure compliance with license details and relevant guidelines and directives.
* Review and approval of all new and revised master batch documentation, QC specifications and packaging work orders in line with license details and relevant standard operating procedures.
* Identification, compilation and approval of Regulatory SOP's.
* Assist in the training of new artwork and regulatory personnel.
* Set timelines for all license and variation approvals.
* Work to department KPIs.
Experience Required:
* Third Level qualification a scientific discipline
* Regulatory experience in a pharmaceutical industry of 3-5 years.
* EU submission experience will be an advantage, but not essential.
Package:
An excellent salary of between €45,000 - €50,000 depending on experience is on offer along with an attractive benefits package including an impressive bonus and pension.
This is a permanent role and is placed in South Dublin, close to the m50 and very accessible via the Luas. Interviews will commence immediately so if you are interested in this Regulatory Affairs job please send an updated CV to Amanda Murphy for consideration or ring me on to discuss further.