We are presently recruiting for a graduate Regulatory Affairs Officer for our clients in Killorglin, County Kerry. Reporting to the Regulatory Affairs manager, you will gain experience in all aspects of regulatory affairs and will be the point of contact for all documentation. This is a full-time position, a hybrid position, based in County Kerry.
Duties:
- Raising of Reg Affairs dept PO’s and following up re: orders, invoices, contract documentation as needed.
- liaising as needed with accounts including monthly reg affairs invoice reconciliation.
- Maintain reg affairs/new product development costs tracker. Including database of annual renewal fees, licensing fees.
- Take responsibility for filing of annual product listings with agencies such as FDA.
- Assist with the preparation of dossier files for initial marketing authorisations including Part 1/Admin sections, Part 2/ CMC pharmaceutical sections.
- Assist with obtaining Free Sale certs, GMP certs, certificates of origin.
- Provide technical and regulatory input to quality team for documentation associated with existing product manufacture.
- Manage and maintain the reg affairs database.
- Manage and maintain new product development documentation.
- Store, manage and maintain documents while ensuring their accuracy and quality.
Requirements:
- Bachelor’s degree in science, (a preference for Chemistry) or Engineering, or a related field
- Experience in a GMP environment.
- Flexibility and initiative to work independently.
Salary is open to negotiation and based on experience. For further information, please email me directly at adrien@redchair.ie
