18 set - Italia
Iqvia
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. This is an opportunity for an early-career regulatory professional to build broader experience across medicinal-product lifecycle activities, regulatory submissions and client support while working alongside experienced Regulatory Affairs colleagues.
Contract: Fixed-term maternity cover
Support the regulatory lifecycle management of medicinal products on the Italian market.
Support submissions and routine communications with Italian health authorities.
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.
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.
Strong planning and organisational skills, with the ability to prioritise activities against different client and authority deadlines.
Good written and verbal communication skills.
Confidence using Microsoft Office and relevant regulatory systems or publishing tools.
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