Regulatory Affairs Analyst

ppMilan, Italy /p pFull time /p pR /p h3Help keep essential medicines available to patients /h3 pAt IQVIA, our Regulatory Affairs teams help pharmaceutical clients navigate regulatory requirements and maintain medicinal products on the market. /p pWe 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. /p pYou will take ownership of routine operational activities, interact with clients and health authorities, and help ensure that regulatory deliverables are completed accurately and on time. /p h3Contract: Fixed-term maternity cover /h3 h3What you will do /h3 ul liSupport the regulatory lifecycle management of medicinal products on the Italian market. /li liPrepare, review and coordinate regulatory documentation and submissions. /li liSupport submissions and routine communications with Italian health authorities. /li liWork with clients to understand requests, coordinate activities and meet regulatory and contractual deadlines. /li liAssist with lifecycle maintenance, marketing authorisation transfers, labelling, CMC activities and other regulatory procedures, depending on project requirements. /li liSupport activities connected with promotional materials and ongoing product maintenance. /li liTrack deliverables, timelines and priorities across several concurrent projects. /li liWork closely with senior Regulatory Affairs colleagues, escalating risks or more complex matters when necessary. /li liParticipate in internal and client meetings and communicate progress clearly. /li liFollow applicable procedures and quality standards while contributing ideas for practical process improvements. /li /ul h3What will help you succeed /h3 ul liA bachelor’s or master’s degree in pharmacy, biology, biotechnology or another relevant life-sciences discipline. /li liApproximately two years of relevant Regulatory Affairs experience. /li liPractical experience supporting operational regulatory activities for medicinal products. /li liPrevious experience in a pharmaceutical company, CRO, consultancy or similar regulated environment. /li liUnderstanding of the Italian regulatory environment and medicinal-product lifecycle activities. /li liExperience preparing or coordinating regulatory documentation and submissions. /li liConfidence communicating with clients, internal stakeholders and, ideally, health authorities. /li liStrong planning and organisational skills, with the ability to prioritise activities against different client and authority deadlines. /li liGood written and verbal communication skills. /li liStrong attention to detail and the ability to follow established procedures consistently. /li liConfidence using Microsoft Office and relevant regulatory systems or publishing tools. /li liFluent Italian and professional working proficiency in English. /li /ul h3Why join IQVIA? /h3 pYou will join a collaborative Regulatory Affairs environment where you can develop your expertise through exposure to different clients, products and regulatory activities. You will be supported by experienced colleagues while having meaningful ownership of day-to-day deliverables and client interactions. /p pThis role offers the opportunity to strengthen your knowledge of the Italian regulatory landscape, broaden your lifecycle-management experience and contribute directly to keeping medicinal products compliant and available to patients. /p h3Working arrangements /h3 pThis is a hybrid position, combining remote working with attendance at the office for face-to-face collaboration. Candidates should therefore be based within reasonable travelling distance of Milan. /p pThe position is offered as fixed-term maternity cover. The exact duration will be aligned with the employee’s effective period of absence, in accordance with applicable Italian requirements. /p h3Join IQVIA and help deliver regulatory work that supports better healthcare outcomes. /h3 pIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at /p pIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. /p pThe potential base pay range for this role, when annualized, is 33 000,00 € - 49 400,00 €. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits. /p pIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. /p pTo get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. /p pEEO Minorities/Females/Protected Veterans/Disabled /p /p #J-18808-Ljbffr