About your new employer
We are looking for a GMP Coordinator to join a pharmaceutical company on a 12-month Maternity leave contract in Co.Cork. In this onsite role, you will support regulatory and compliance activities. This is an exciting opportunity to work collaboratively with global and local teams.
About your new job as a GMP Coordinator
- Collaborate with regional leads and local teams to coordinate, communicate, plan, and submit site GMP and compliance-related content for marketing applications and establishment licenses.
- Develop and/or review regulatory documents to ensure accuracy, completeness, and compliance with relevant standards.
- Support the creation and tracking of timelines to align submissions with program milestones.
- Maintain and update dashboards to monitor progress on regulatory document preparation, working closely with regulatory and quality teams.
- Attend functional area and project team meetings as required.
- Process documentation requests to support application activities.
- Assist in preparing for interactions with global regulatory authorities.
- Coordinate requests for agency-issued documentation (e.g., FDA Certificates of Pharmaceutical Product, site manufacturing licenses), notarization, and legalization.
- Manage the system for Regulatory CPP/CMP and document authentication requests.
- Track GMP/site registration renewal timelines alongside local teams.
What skills/experience you need as a GMP Coordinator
- Bachelor’s degree in life sciences, chemistry, molecular biology, or a related field (preferred).
- Minimum of 2 years’ experience in Regulatory Affairs, Quality, or Process Development.
- Experience working within a global pharmaceutical or biotechnology company.
- Proficient in writing and editing technical documents.
- Strong project management skills (preferred).
What’s on offer for you as a Validation Engineer
- Hourly rate DOE
- 12-month contract
What's Next
Ready to take the next step in your career? Apply now by clicking the “Apply Now" button or call Elaine McCarthy at +353 21 4847135. If this job isn't quite right but you're looking for something similar, please get in touch. We also have multiple Temp, FTC, and Contract jobs available.