Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

Google Chrome
Internet Explorer
Mozilla Firefox

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Apply for this job






Salary Expectations:



Current Location:

Notice Period:

Write here your cover note:

If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box

If you are having difficulty you can always email your cv to

Research and Development Compliance Specialist

Reference:ANYG-747027 Location: Galway
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed

Research and Development Compliance Specialist
Our Galway based client are currently recruiting for an R&D Compliance Specialist role to join their team on a permanent basis. The successful candidate will be responsible for reviewing & approving all analytical data for the R&D departments within the organisation.

• Review and approve the analytical data for the Pilot batches testing and the process validation. Ensure the data is correct and no deviations made
• Review and approve the method validation protocols and reports
• Review and approve the analytical method transfer protocols and reports
• Review and approve the stability reports for the optimization and pilot batches and ensure the data is reported accurately
• Review and approve the COAs
• Review and approve specific reports prepared for the regulatory submission by cross-referring to the raw data
• Co-ordinate with registration team for responding to the queries from regulatory agencies and customers
• Support R & D team in responding to the queries received from the regulatory agencies
• Review and approve the working standards preparations and ensure they are used within the shelf life and no deviations made
• Maintain the log of Dissolution and HPLC and any other instruments’ calibration and ensure that the calibrations are performed as per the schedule. If required address the technical issues
• Review HPLC data by logging into empower and ensure GLP is followed.
• Preparation of Bulk hold time study protocols
• Review the analysts’ logbooks and approve the data
• Review and approve the deviations/OOS for the Development project

• Degree in Science Discipline or equivalent
• 5 – 10 years’ experience within the pharmaceutical industry in the relevant field
• Sound knowledge of empower/GMP/GLP
• Strong time management and organisational skills

If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252

Business Development Hospital Sales Rep Regulatory Affairs Specialist Research and Development Quality Manager Microbiology Lab Supervisor Healthcare QA Manager Research and Development Scientist Quality Control Manager Engineering Medical Affairs QA Analyst Regulatory Affairs Principal Scientist Kildare Automation Engineer QA Director Waterford Pharmaceutical Dublin Contract Limerick Galway Design Engineer BD Manager QA Specialist Sales Executive Account Manager QA Supervisor Supply Chain Coordinator QA Executive Dublin North Molecular Biologist Dublin City Centre Regulatory Affairs Executive Supply Chain Administrator Supply Chain Manufacturing Coordinator Biopharmaceutical Manufacturing Executive Project Lead Business Development Executive EHS Engineer Project Engineer Chemistry PhD Regulatory Affairs Officer Validation Engineer Supply Chain Quality Assurance Officer Supply Chain Specialist Formulation Chemist Life Science Sales Manager Dublin South EHS Specialist Quality Assurance Engineering Microbiology Analyst Sligo BD Executive Scientific Production Supervisor Sales Development Executive Nurse Associate Life Science Regulatory Affairs Manager Regulatory Affairs Planner Microbiologist Quality Control Supervisor Regulatory Affairs Director Contract Research and Development Engineer Qualified Person Microbiology Dublin West Republic of Ireland Food Scientist Equipment Engineer Scientific Sales Biotechnology Chemist Process Development Engineer Connected Health Product Specialist Scientist Formulation Scientist Cork Business Development Manager Clinical Research Senior Research and Development Engineer Medical Advisor Process Engineer Medical Device