Regulatory Affairs Analyst

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8cxavh

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,

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8cxavh