Help keep essential medicines available to patients At IQVIA, our Regulatory Affairs teams help pharmaceutical clients navigate regulatory requirements and maintain medicinal products on the market. We are looking for a Regulatory Affairs Analyst to join our team in Italy.
Contract: Fixed-term maternity cover
What you will do
- Support the regulatory lifecycle management of medicinal products on the Italian market.
- Prepare, review and coordinate regulatory documentation and submissions.
- Support submissions and routine communications with Italian health authorities.
- Work with clients to understand requests, coordinate activities and meet regulatory and contractual deadlines.
- Assist with lifecycle maintenance, marketing authorisation transfers, labelling, CMC activities and other regulatory procedures, depending on project requirements.
- Support activities connected with promotional materials and ongoing product maintenance.
- Track deliverables, timelines and priorities across several concurrent projects.
- Work closely with senior Regulatory Affairs colleagues,
escalating risks or more complex matters when necessary.
- Participate in internal and client meetings and communicate progress clearly.
- Follow applicable procedures and quality standards while contributing ideas for practical process improvements.
What will help you succeed
- A bachelor’s or master’s degree in pharmacy, biology, biotechnology or another relevant life-sciences discipline.
- Approximately two years of relevant Regulatory Affairs experience.
- Practical experience supporting operational regulatory activities for medicinal products.
- Previous experience in a pharmaceutical company, CRO, consultancy or similar regulated environment.
- Understanding of the Italian regulatory environment and medicinal-product lifecycle activities.
- Experience preparing or coordinating regulatory documentation and submissions.
- Confidence communicating with clients, internal stakeholders and, ideally,
📌 Regulatory Affairs Analyst (Italia)
🏢 Iqvia
📍 Italia
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