We are seeking a Regulatory Affairs Manager for Greece who will be responsible for submitting renewals, variations, post-market and market approvals, lifecycle management, etc., to the Greek Health Authority.
Act as a Regulatory Manager on complex projects with guidance from senior staff, when appropriate.
Write regulatory documents with minimal review by senior staff.
Provide guidance to junior colleagues, including feedback on technical documents, and assist in their training and development.
Present to clients at bid defense meetings, either by phone or in person, for a range of regulatory deliverables, as directed by senior staff.
Write or propose revisions for new regulatory standard operating procedures, and/or act as a reviewer for these procedures, as assigned.
Regular travel to the Greek Health Authority in Athens (a home-office printer may be provided by IQVIA).
Bachelor's Degree or Master's Degree in Lifescience or related discipline.
5+ years of relevant experience.
Specific regulatory or technical expertise and sufficient knowledge of managing regulatory projects and project deliverables in a timely manner.
Expertise in planning and delivering work while maintaining quality standards.
Knowledge of regulatory procedures in Greece, especially marketing authorization transfers and relevant cross-functional dependencies.
Good working knowledge of regional regulatory intelligence.
Experience in regulatory strategy, documentation requirements, timelines, and budgets for MATs and publishing projects.
Fluency in the Greek language.
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IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
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