Regulatory Affairs Specialist
About the role
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- Overall decision responsibilities in regard to resourcing, line management, training, functional delivery and agreeing high quality measurements within the SISA function
- Supporting the feasibility outreach in the region during proposal stage.
- Leading the overall delivery, through your SISA team, to drive execution of service, customer satisfaction, quality and efficiencies.
- Providing project oversight for all allocated studies.
- Provide effective management support to your team that delivers a high performing culture. Carrying out all relevant line management responsibilities including appraisals, goal setting and development plans.
- Responsible for hiring in the region whilst ensuring operations is conducted in line with relevant margins.
- Oversight and execution of all SISA, to achieve rapid site activation, ethical submissions, site contracts and drug release processes.
- Communicate with the VP Clinical and other peers in the region on all critical issues and business growth opportunities.
- Communicate with VP PMs on all client deliverables.
- Will support Business Development in the selling and understanding of the SISA function and how this is beneficial to the client’s deliverables and how we can reduce timelines.
- Developing key relationships with customers and where needed participate on customer satisfaction initiatives.
- Working closely with the functional head of SISA so that global consistency, focus and development are achieved across the Lead function Develop and maintain positive relationships with our clients.
- Drive innovation and continuous improvement in all areas of responsibility.
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