17 ott - Milano
Iqvia
pHelp 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. /ppContract: Fixed-term maternity cover /ph3What you will do /h3ulliSupport the regulatory lifecycle management of medicinal products on the Italian market. /liliPrepare, review and coordinate regulatory documentation and submissions. /liliSupport submissions and routine communications with Italian health authorities. /liliWork with clients to understand requests, coordinate activities and meet regulatory and contractual deadlines. /liliAssist with lifecycle maintenance, marketing authorisation transfers, labelling, CMC activities and other regulatory procedures, depending on project requirements. /liliSupport activities connected with promotional materials and ongoing product maintenance. /liliTrack deliverables, timelines and priorities across several concurrent projects.
/liliWork closely with senior Regulatory Affairs colleagues, escalating risks or more complex matters when necessary. /liliParticipate in internal and client meetings and communicate progress clearly. /liliFollow applicable procedures and quality standards while contributing ideas for practical process improvements. /li /ulh3What will help you succeed /h3ulliA bachelor’s or master’s degree in pharmacy, biology, biotechnology or another relevant life-sciences discipline. /liliApproximately two years of relevant Regulatory Affairs experience. /liliPractical experience supporting operational regulatory activities for medicinal products. /liliPrevious experience in a pharmaceutical company, CRO, consultancy or similar regulated environment. /liliUnderstanding of the Italian regulatory environment and medicinal-product lifecycle activities. /liliExperience preparing or coordinating regulatory documentation and submissions. /liliCon
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