Regulatory Systems Business Support Manager

2 days ago


Dublin, Ireland Tandem Project Management Limited Full time

Summary: A Regulatory Systems Business Support Manager is required for a biopharmaceutical company in West Dublin. The successful candidate will be responsible for managing an ongoing Veeva to Veeva regulatory information management system migration. Ensuring all documentation, regulatory information, and submitted archives are enriched and are successfully transferred to the new RIM system. Responsibilities: Executing planned activities within the migration plan as appropriate to ensure the project is on track. Providing oversight and direction towards the mapping requirements between the two Veeva RIM systems. Ensuring successful deployment of successful migration strategies. Ensuring compliance with all relevant regulations and internal policies throughout the migration process. Providing insight and technical knowledge towards the enrichment of regulatory data if necessary. Assisting the Systems and digital lead as necessary throughout the project. Assisting with migration verification strategies, risk assessment and cut-over strategies. Collaborating with stakeholders as and when necessary to gather enriched data requirements and resolve any issues or discrepancies that arise. Qualifications & Experience: Bachelor's degree in a relevant discipline. Minimum 4 years of experience in the pharmaceutical/biotech industry, within Global Regulatory Affairs, Clinical or Regulatory Operations, supporting systems. Experience within a Veeva Regulatory Information Management system is a necessity. preferably a white belt or a system administrator training. Significant knowledge of Regulatory Affairs business processes, preferably experience with a regulatory information management migration project. Demonstrated experience managing, developing, and administering electronic document management systems, regulatory publishing systems and regulatory tracking databases. Experience in maintaining GxP, Annex 11 and 21 CFR Part 11 computerized systems. Skills: Global Regulatory Affairs Clinical Regulatory GxP Veeva



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