Description
My client, a pharmaceutical and medical device company, is urgently recruiting a Regulatory Affairs Officer to join their team in Dublin. The successful candidate will work on the submission of license applications, variations and renewals worldwide, and ensure that all new license and variation applications are planned, tracked and obtained in a timely manner.Responsibilities:
- Submission of license applications, variations and renewals worldwide.
- Ensure that all new license and variation applications are planned, tracked and obtained in a timely manner.
- Ensure all operations are fully compliant with license details and updated in accordance with relevant guidelines and directives.
- Review of internal documentation to ensure compliance with license 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.
Minimum Requirements:
- Bachelors Degree in a scientific discipline.
- Regulatory experience in a pharmaceutical industry of 2-5 years is essential.
- EU submission experience essential and a QC background would be an advantage.
This is an urgent requirement and interviews will take place immediately.
If you are interested in this role call me,, Adele Moran, on or reply to this email. Sthree UK is acting as an Employment Agency in relation to this vacancy.