Matrix Recruitment are seeking to recruit Reg Affairs Site Officer for our well-established pharma client, based in the Waterford area.
This is a 23-month contract, opportunities onsite.
Day role with flexible working arrangements.
You will work with the Site Regulatory team in support of product registrations and dossier management while playing a part in supporting Site strategy and GRA initiatives.
Key duties & responsibilities:
- Support product evaluations / changes with regard to regulatory assessment and product transfers.
- Collaborate with local and Global (Development, Technical, Regulatory, Operational and Quality) stakeholders with regard to New Product Introduction – clinical supply, BLA submission, etc.
- Performs troubleshooting, (cross functional-) investigations, continuous improvements, formal and informal regulatory risk assessments.
What are we looking for?
- Minimum degree in Science. Ideal – MSc or PhD in a relevant discipline.
- Significant experience in Regulatory CMC role in the pharma or biopharma sector.
- Pharma site CMC experience essential.
- Liaising with QC/Project and Validation departments.
- Batch release and generation of annual product quality reviews.
- Managing renewals.
Apply for this job now by emailing your WORD formatted CV to Joanne
Please note that due to the expected high volume of applications we can only reply to applicants suitable for the position. In the interest of protecting your data and informing you of your rights we will notify you should we retain your information by issuing an acknowledgement email and a request for consent where not already expressly given.
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