Regulatory Affairs Associate

Parexel International Corporation

Italy, Remote

This role can be either office based in Milan, or you can be fully home based anywhere in Italy. The office is open planned, and you will be working in an innovative and collaborative environment connecting with colleagues from around the world. This Regulatory Affairs Associate  may work on some clinical trials as a LRC (local regulatory contact) for Italy and/or as EU RL (regulatory lead) for clinical trial applications submitted according to the EU CTR. Experience in submission of variations to marketing authorization is also desired.

Education:- Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree PreferredLanguage skills :- Must be fluent in Italian andEnglish communication skills in both written and verbal format .Skills:- High-level consulting skills- Critical thinking and problem-solving skills- Project leadership and management knowledge- Excellent interpersonal and intercultural communication skills, both written and verbal- Client-focused approach to work- Results orientation- Teamwork and collaboration skills- Proficiency in local language and extensive working knowledge of the English language- Networking- Business analysis- Self-confidence and controlKnowledge and Experience: - Strong experience working in a CRO industry-related environment; experience with a regulatory agency (such as FDA, MHRA) is a plus- Previous experience of managing and submitting marketing authorization dossiers for Italy is beneficial- Previous CRO / Pharma experience working in the capacity of a Regulatory Affairs with CTA submission knowledge and CTR Experience is essential.- Client-focused approach to work In return we will be able to offer you a structured career pathway and development within the role including awareness and understanding of the industry. Your hard work will be rewarded with a competitive salary, bonus and benefits package including days holiday and other leading edge benefits that you would expect with a company of this type.

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