Regulatory Affairs Officer 12 Month Cont

CPL

Dublin West

On behalf of our client, a global pharmaceutical company, we are currently recruiting for a Regulatory Affairs Officer 12 month contract. In this role, you will: Obtain and maintain all necessary licences (Marketing Authorisations (MA’s), Clinical Trial Authorisations (CTA's) Etc.) for a designated list of products. Maintain an awareness of current Irish & EU regulatory requirements. Submit applications (new MA's/Clinical Trials/Variations/Renewals etc.) for National/EU MA's and negotiates with the Health Products Regulatory Authority (HPRA) to resolve any issues to minimise the delay in approval. Ensure prompt resolution of regulatory issues affecting the Irish business. Communicate significant regulator issues/developments to commercial and the potential impact on the Ireland business. Liaise with UK, European and Global groups on regulatory issues as relevant. Liaise and attend meetings with other company functions to provide regulatory advice for new products, indications, promotional campaigns etc. Review of product information and promotional material prior to re lease. Cover all Regulatory aspects of pharmacovigilance. Maintain compliance of regulatory based labelling (Summary of Product Characteristics (SPC), Package Leaflet (PL) and Prescribing Information (PI)). Maintenance and update of all internal required reporting activities and databases ( Launch Excellence, Monthly Report etc.). Maintain awareness of current and new legislation/ guidance and ensure that work is in compliance with the requirements. Develop and maintain regulatory Standard Operating Procedures (SOP's) as required and provision of regulatory support during inspections and audits. Strategic Input & Regulatory Intelligence: provide strategic regulatory input and support to the Ireland business. Build relationships with the HPRA, Irish Pharmaceutical Healthcare Association (IPHA) and other relevant organisations and personnel both internally and externally. Gain regulatory approvals by appropriate negotiation with the HPRA and/or EU and Global groups. Anticipate and monitor changes in National and EU regulatory requirements in order to contribute effectively to product development and regulatory strategies. Monitor the regulatory landscape for generic, parallel import and competitor activity as relevant. Education & Experience: For this role, you should have: A Third level degreequalification in Life Scienceor similar. At leasttwo years experience of working in a regulatory position is required. Knowledge and experience of GDP and GCP regulatory environments would be beneficial. Excellent team working and communication skills. Strong negotiation, influencing, presentation skills. Strong visionary, strategic, tactical and motivational skills. If you are interested in applying for this role please call Linda on +353 1 2784671 or email ldunne@thornshaw.com. Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com #THR2018. This job originally appeared on RecruitIreland.com.

1919 days ago