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Regulatory Affairs Officer

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Primary Location: Bucharest, Romania Additonal Locations: Barcelona, Spain,ESP; Belgrade, Serbia,SRB; Bratislava, Slovakia,SVK; Budapest, Hungary,HUN; Kaunas, Lithuania,LTU; Kiev, Ukraine,UKR; Madrid, Spain,ESP; Milan, Italy,ITA; Oeiras, Portugal,PRT; Prague, Czech Republic,CZE; Riga, Latvia,LVA; Sofia, Bulgaria,BGR; Tartu, Estonia,EST; Warsaw, Poland,POL; Zagreb, Croatia,HRV Full time R1277177

Job description

Job Overview
Individual contributor who is fully proficient in applying subject matter knowledge for a professional discipline. Works under limited supervision.

Essential Functions
• Acts as a Regulatory Team Leader on more complex projects, which may include technical writing;
• Prepares and/or reviews regulatory documentation in area of expertise, as appropriate;
• Establishes relationships with many customers;
• Acts as an expert in Regulatory knowledge in Clinical Trials;
• Understands the Scope of Work, deliverables and management of budget for any given project
• May give guidance to junior colleagues and may assist in their training and development;
• May present to clients on complex regulatory processes at large full service bid defense meetings
• May prepare and deliver regulatory training to IQVIA
• Performs other tasks or assignments, as delegated by Regulatory management;

Qualifications
• Bachelor's Degree Degree in Life-science or related discipline OR Master's Degree Degree in Life-science or related discipline
• At least 3-4 years relevant experience
• Possesses a specific regulatory and technical expertise;
• Good interpersonal communication and organization skills;
• Ability to establish and maintain effective working relationships with coworkers, managers and clients;
• Ability to work on several projects, with direction from senior staff as appropriate;
• Ability to make decisions on discrete tasks under senior supervision;
• Ability to adapt quickly to a rapidly changing environment;
• Demonstrates self-motivation and enthusiasm;

• Strong software and computer skills

• Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate;

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world.  Learn more at

https://jobs.iqvia.com

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