Senior Regulatory Affairs Executive- Tipperary

ICDS RECRUITMENT

Tipperary

Senior Regulatory Affairs Executive- Tipperary. Core Purpose. The Senior Regulatory Affairs Executive is the critical and final link that turns scientific and technical effort into commercial product for sale. The job requires a methodical approach, yet creativity and a dynamic approach are necessary to produce prompt results. The role will require the incumbent to collate, prepare and progress renewals, variations and marketing authorisation applications and to supervise the administration of the eMC website and ensure EVMPD compliance in line with compliance & regulatory requirements. Core Responsibilities. Comply with SOPs and assist in their development and review. Operate and propose improvements to internal systems. Assist in the development of regulatory strategies. Determine and communicate submission and approval requirements. Assess the acceptability of documentation for submission. Coordinate and prepare submission packages for regulatory agencies. Monitor the content of the dossiers ensuring the content is consistent, understandable and the results clearly expressed and that open questions have been dealt with. Respond to questions raised by regulatory authorities by obtaining the relevant information from departments concerned. Negotiate with regulatory authorities to achieve most favourable conditions for marketing authorisations or variations. Commission and approve artwork for compliance prior to final signoff. Draft Summary of Product Characteristics, Patient Information Leaflets and packaging. Monitoring legislation and professional publications to maintain awareness of current regulatory practice and provide information on regulatory requirements to other departments and/or business units. Respond to external/internal regulatory information requests. Review GMP documentation for regulatory compliance, as directed. Represent regulatory affairs at internal and external meetings as directed by the Regulatory Affairs Manager. Operational use of and input to the Pharmaceutical Quality System will be achieved by maintaining the integrity of the Pharmaceutical. Quality Systems, by engaging with and utilising the system in accordance with defined procedures and policies. Contribute to improving the effectiveness of the Pharmaceutical Quality Systems by collection of metric data and other essential associated information which measures the system performance. Contribute to and participate in continuous improvements to products, processes and the Pharmaceutical Quality System with the aim of minimising patient, customer and business risks. Key Performance Targets. Understanding and interpreting complex regulatory legislation and successfully challenging regulatory agencies’ interpretation thereof, when necessary. Having a broad understanding of all matters concerning the safety, quality and efficacy of both existing and new products. Achieving results within tight time frames. Diplomatically guiding other departments along correct path to ensure regulatory approval. Producing regulatory documentation to the highest possible standard. Qualifications & Experience. Educated to at least degree level in a life science with significant experience in regulatory affairs. Membership of The Organization for Professionals in Regulatory Affairs (TOPRA) is preferable. Ability to organise own workload with a minimum of supervision. He/she should have a basic appreciation of all aspects of the working of the pharmaceutical industry. Experience with information technology desirable. Exceptional eye for detail required. Requires the ability to present the Company’s interests in a professional and authoritative manner and to conduct negotiations with regulatory bodies. Apply below or contact Sean Fitzsimons at ICDS Recruitment for more details & to discuss the position in confidence .

1153 days ago