Our client a Global Pharmaceutical Company have opened a new vacancy within their Regulatory team. We are looking to recruit a Regulatory CTA Contractor on a 12 month contract to be based in Berkshire after COVID.
Clinical Trials Contractor, Regulatory Affairs
- Provide comprehensive strategic and operational support to ensure regulatory approval and compliance for clinical trials conducted in specified regions e.g. Western Europe (WE) and Eastern Europe Middle East and Africa (EEME&A), Latin America (LA) & Japan and Asia Pacific (JAPAC) region
- Work with the Global regulatory lead and other cross functional contacts responsible for development compounds with strategic and operational advice for clinical trials
Clinical Trial Subject Matter Expert
- Provide advice on submission strategy (e.g. VHP vs. National), contribution to substantial & non-substantial decisions for amendments, safety reporting processes, distribution and supply issues, GCP & safety issues and country specific requirements.
- Serve on CTA submission team meetings as area and affiliate strategy regulatory representative
- Provide ad hoc support for CTA related projects throughout the organisation.
- Manage a portfolio of CTAs including preparation and distribution of documentation associated with new initial CTAs and all CTA maintenance activities; substantial amendments, end of trials notifications etc.
- Preparation of cover letters, Annexes 1, 2 and 3, liaison with VHP-coordinator
- Liaise with key contacts in Regulatory Affairs, Clinical Study Management, Clinical Operations, Supply Chain and local affiliates to identify & resolve issues
- Input into CA response to questions/requests for information
- Support inspection readiness activities when applicable
Project Management, Process Compliance and Communication
- Ensure approved company CTA processes are followed within agreed timelineUndertake all necessary training in order to achieve compliance with internal/external processes
- Ensure all relevant databases and activity trackers are populated within agreed timelines and compliance/reporting requirements met
- Monitor key project milestones, communicate changes to assigned stakeholders and management as agreed in company procedures
- Participate in process improvement initiatives
- Support SOP reviews and updates as required
- Life sciences degree and relevant experience or PhD or equivalent relevant experience.
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: Natasha.Rollason@srgtalent.com or +441753 589673
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