Snr Regulatory Affairs - Waterford
The Role 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. The Person Strong communication skills (interpersonal, presentation & writing. 3 rd Level Diploma/Degree in Science, Pharmacy or related discipline. Experience dealing with combined products. Experience with Biologics. Ability to effectively communicate technical & non-technical information. Highly motivated and has the ability to multi-task. 10 years experience. Strong leadership skills. Hartley People Recruitment work to the highest ethical standards within our industry and we value the trust that you place in us when you send your CV. We can provide a full consultation in confidence and we guarantee that your CV will not be sent to any of our clients without your prior consent. For immediate consideration please call Sara on 051-878813 or email your CV in response to this job posting. Hartley People also recruit for similar roles such as Quality Control Manager, Quality Control Technician, Quality Assurance Manager, Quality Assurance Technician, New Product Development Manger, Quality Systems Manager, New Product Development Co-ordinator, Supplier Assurance Manager.
Waterford, Tipperary, Kilkenny
174 days ago