Description
We are seeking a Regulatory Affairs Manager for Greece, based in Athens or within a commuting distance, who will be responsible for submitting renewals, variations, post-market and market approvals, lifecycle management, to the Greek Health Authority.
Essential Functions
- 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.
- Regularly travel to the Greek Health Authority in Athens.
Qualifications
- Bachelor's Degree or Master's Degree in Lifescience or related discipline.
- Minimum 5+ years of relevant experience in post-marketing maintenance, lifecycle management regulatory affairs on Greek market.
- Specific regulatory or technical expertise and sufficient knowledge of managing regulatory projects and project deliverables in a timely manner.
- Strong communication and presentation skill as this is a client facing role.
- 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.
- Native Greek as well as full working proficiency in English language.
The potential base pay range for this role, when annualized, is 44,200.00 € - 66,200.00 €.