Job Description SummaryRegulatory Affairs TraineeAbout the role: Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates.
This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.Join us as a Founder of our 'new' Sandoz!Commitment to Diversity Inclusion:We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.What are you going to do?Authorization processing management support (new MAs)Text preparation: translations and fractionationManagement of national phases after EoP, including fractionationPreparation of national documentation for presentation (PoP, texts)Trade management, including databases and systemsFractionation management after variation submissionPreparation of national documentation for submission (PoP, texts, e-application form...)eCTD submissionSwitch/transfer support: PLC and technical informationPruning portfolio review support/executionGeneral support for specific activities/projectsDatabase maintenance and compliance - RegDB (including Art.
57), Excel spreadsheetsRole Requirements:A career in pharmacy or ADEMaster's Degree in Pharmaceutical Industry or Master's Degree in Registration of Industrial Medicines (CESIF, Official College of Pharmacists, IMF)English level C1 - C2Open-minded person who can be a facilitator, stress tolerant, team player, able to prioritise, organised, attention to detailOffice administration (Advanced Word, Excel)Desirable requirements:Nice to have previous experienceGood knowledge of Portuguese Basic/IntermediateWhat's in it for you?Place of Work: Madrid (Hybrid Modality).Flexible Schedule: from Monday to Thursday from 8:00-9:30 to 17:30-19:00, on Fridays from 8:00-9:30 to 14:00-15:30.Internship Duration: 12 months.Competitive Retribution and Social Benefits.
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