Global Regulatory Affairs Operations Specialist - Regulatory Publishing

Overview

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 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.

 

This is a maternity leave coverage.

Main Activities & Responsibilities

• Plan 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);
• Check 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;
• Develop and implement templates for streamlining the preparation of documents for effective regulatory submissions;
• 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 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;

• Actively participate in project teams;
• Monitor 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;

Job Requirements

• Master’s degree or higher in scientific discipline, information technology, or a related field;
• 3+ years’ experience in the Regulatory Affairs and / or Operations or related discipline preferably in the pharmaceutical industry;
• Aptitude for IT environment (basic and specific software to be used);
• Good experience in document publishing and sequence publishing activities;
• Competent user of docuBridge and basic knowledge of Veeva RIM suite;
• Good spoken and written English;
• Dynamic, proactive and willing-to-do person; 
• Excellent analytical, problem solving and communication skills;
• Excellent planning and organizational skills;
• Excellent team player with the ability to work effectively across all organizational levels.

 

 

The 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.