Regulatory Affairs Site Officer

Hartley People

Waterford, Kilkenny, Wexford

The Role Manage regulatory issues locally at site, supporting improved compliance and regulatory awareness. Ensure that only Products meeting all appropriate testing and release criteria are released to market. Act as liaison with regulatory authorities, supporting new product and variation approvals. Oversees the day to day management of RA systems, directing the workload of the RA Team. Review and approval of appropriate documents e.g. PMF, SMF. Evaluate the regulatory impact of proposed changes at the sites. Communicate proposed CMC changes for prioritization as necessary. Maintain regulatory documents such as Site Master Files. Co-ordinate preparation of Product Quality Reviews and Annual Reports (US market. Represent site at global Regulatory Affairs meetings. Ensure the appropriate involvement of corporate RA-CMC personnel as necessary. Maintain complete copies of CMC documents submitted to and approved by Regulatory Authorities. The Person Degree in Science, Pharmacy or related discipline essential. Post Graduate Studies as appropriate to augment Primary Degree. Eligibility to act as Qualified Person an advantage. Minimum 3 years’ experience in a similar role, working with international regulatory authorities. Experience of manufacturing operations, dealing with regulatory authorities, and working through Corporate structures highly desirable. Experience working as a QP in release of products to market. 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 Production Supervisor, Production Manager, Lean Manufacturing, Six Sigma, GMP, FDA, Production, Engineering, Manufacturing, Pharmaceutical, Medical, Devices. ISO 9000, Manufacturing Manager, Operations Manager, Assistant Operations Manager, Production Team Leader, Line Manager, Line Leader.

2342 days ago