Global Regulatory Affairs Operations Specialist

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8hgn68

Questa posizione è in Menarini Il processo di selezione sarà interamente gestito Menarini.
-- 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 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 an

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8hgn68