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Regulatory Site Officer

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Waterford
  • Sector: Science
  • Date posted: 12/07/2017
  • Job reference: J368628A

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Regulatory Site Officer

New permanent opportunity with an established biopharma organisation. The ideal candidate will be interested developing a career in Regulatory Affairs. This position will offer the possibility of career advancement and professional growth within an exciting area of the pharmaceutical industry.

You will join the RA team and you will have a key role in supporting activities at an expanding manufacturing site where both oral dose and aseptic parenteral drug products are manufactured for global markets. Therefore, past experience with clinical trials would be beneficial.

Key Duties will include:

· Review and evaluate the regulatory impact of proposed changes at the site.
· Support New Product Development Projects and continuous improvement initiatives for existing products/processes
· Provide guidance to project teams on the technical data package needed to support filings for changes to product operations (for commercial and clinical trial use) and product transfers to and from site.
· Compilation of information for use in global filings.
· Ensure appropriate communication of RA variation approvals, indicating when approved changes with RA impact can be implemented.
· Compilation and maintenance of Product Specification Files
· Maintenance of Site Master Files/Plant Master File.
· Maintain IMB manufacturing licenses and provide RA guidance into major deviations as appropriate.
· Preparation of Periodic Product Reviews (Annual Product Reviews) and support Annual Report preparation as required
· Continuous Improvement of Regulatory Affairs processes and procedures
· Review and approval of site documentation ensuring compliance with regulatory commitments and registered product details (e.g. batch records, material specifications, protocols and reports (e.g. PQs and PVs), stability documentation, etc
· Review and approval of artwork


· Excellent communication skills (interpersonal, presentation & writing)
· Ability to effectively communicate technical & non-technical information
· Works well with others at all levels of the organisation, across multi-sites, and in a multi-national environment
· Initiative - able to work in a self-directed manner to see issues through to completion.
· Highly motivated and has the ability to multi-task


Degree/Diploma in Science, Pharmacy or related discipline is essential