Global Regulatory Affairs Operations Specialist - Regulatory Publishing

ph3Overview /h3 /brpWithin 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 Global Regulatory Affairs Operations Team Leader - Regulatory Publishing (RP) will be responsible for the preparation, assembly and delivery of accurate, complete and effective regulatory submissions (new registrations and / or maintenance of the existing ones) in electronic format. /p /brpWithin 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 Global Regulatory Affairs Operations Team Leader - Regulatory Publishing (RP) will be responsible for the preparation, assembly and delivery of accurate, complete and effective regulatory submissions (new registrations and / or maintenance of the existing ones) in electronic format. /p /brpThis is a maternity leave coverage. /p /brh3Main Activities Responsibilities /h3 /brul /brliPlan and organize of the activities needed for the preparation of the regulatory submissions in electronic format in close cooperation with involved stakeholders (Global, Regional, Local); /li /brliCheck the compliance with company’s quality standard of documents and with the requirements for the submission in electronic format (eSubmission-ready documents); give advice on authoring of documents with the aim of exploiting the advantages of the electronic submission; /li /brliDevelop and implement templates for streamlining the preparation of documents for effective regulatory submissions; /li /brliLiaise with and support other company’s departments in their activity of preparation of documents compliant to the requirements for the submission in electronic format; /li /brliParticipate in company’s projects or initiatives i) to select and implement software solutions for regulatory purpose in the Menarini Group, and ii) to foster their use in a harmonized and validated approach and to improve best practices and working processes; /li /brliActively participate in project teams; /li /brliMonitor and disseminate through ad hoc communications the information on global requirements relevant to the submission in electronic format and assess their impact on the Menarini projects; /li /br /ul /brh3Job Requirements /h3 /brul /brliMaster’s degree or higher in scientific discipline, information technology, or a related field; /li /brli3+ years’ experience in the Regulatory Affairs and / or Operations or related discipline preferably in the pharmaceutical industry; /li /brliAptitude for IT environment (basic and specific software to be used); /li /brliGood experience in document publishing and sequence publishing activities; /li /brliCompetent user of docuBridge and basic knowledge of Veeva RIM suite; /li /brliGood spoken and written English ; /li /brliDynamic, proactive and willing-to-do person; /li /brliExcellent analytical, problem solving and communication skills; /li /brliExcellent planning and organizational skills; /li /brliExcellent team player with the ability to work effectively across all organizational levels. /li /br /ul /brpThe selected candidate will be employed under Category \"B\" in accordance with the provisions of the current National Collective Bargaining Agreement (CCNL) for the Chemical and Pharmaceutical Industry, including all applicable contractual and remuneration terms, and in compliance with Legislative Decree No. 96/2026. /p /p #J-18808-Ljbffr