Operational Associate - Global Regulatory Affairs Operations, Regulatory Publishing Firenze

Operational Associate - Global Regulatory Affairs Operations, Regulatory Publishing
Firenze
Toscana, Firenze

Talent Solutions, part of Manpower Group, for an important pharmaceutical client based in Florence, is currently recruiting for aOperational Associate, Global Regulatory Affairs Operations, Regulatory Publishing Within the Global Regulatory Affairs Operations department, whose mission is to provide timely and high quality regulatory submission ready packages to facilitate faster time to market, while driving business solutions that support the company's cross-functional processes and advancing company's digital capabilities, the resource, reporting to the Lead, Global Regulatory Affairs Operations, Regulatory Publishing (RP) will be responsible for the operational activities related to the preparation, assembly and delivery of accurate, complete and effective regulatory submissions (new registrations and/or maintenance of the existing ones) in electronic format (including but not limited to: document publishing and sequence publishing levels, delivery and archiving, internal / external support).

MAIN ACTIVITIES AND RESPONSIBILITIES• Participate in the activities related to the preparation of the regulatory submissions, in close cooperation with other RP roles;• Check the compliance with company's quality standard of documents and with the requirements for the submission in electronic format (eSubmission-ready documents);• Execute practical and technical tasks related to document publishing level, sequence publishing level, delivery to internal and external stakeholders of regulatory packages in electronic format and relevant archive;• Liaise with and support other company's departments in their activity of preparation of documents compliant to the requirements for the submission in electronic format;• Participate in the activities related to i) the use and maintenance of the configured, implemented and validated software solutions, and ii) the management of troubleshooting;• Monitor and disseminate through ad hoc communications the information on global requirements relevant to the submission in electronic format in order to support the unit task to disseminate the above information in the Group.

JOB REQUIREMENTS• Bachelor's degree preferred in scientific fields;• Good spoken and written English;• Aptitude for IT environment (basic and specific software to be used);• The candidates should be dynamic, proactive and willing-to-do person; • The candidate should have good communication, problem solving and team working skills Contract type: Fixed-term contract of 1 year depending on the starting date with possible extension. Location – Florence, hybrid position Scientific Degree; Good spoken and wtitten English; Aptitude for IT environment