Global Regulatory Affairs Operations Specialist
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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.
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Florence, Tuscany, Italia MENARINI Group Tempo pienoOverviewWithin 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...
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