Job Description

2023 will potentially see Sandoz become a standalone organization! Already a global market leader in Generics and Biosimilar medicine, this is an exciting, once-in-a-career opportunity to set our own path forward as an independent, passionate organization, and as the founders of a new Sandoz, this is a time of immense opportunity for us all, both professionally and personally! Together we will shape the future of Sandoz are you ready to make a difference Job Purpose: Ordering, coordination and tracking of submission relevant items (e.g. CoPP certificates, QP declarations, samples, GMP/ ML). The specialist follows agreed processes and supports optimization, implementation and maintenance of a new and / or updated business processes in the area of responsibility. In close cooperation with other Regulatory Operations functions, relevant Regulatory Affairs (RA) and non-RA stakeholders ensures efficient workflow for concerned areas. This includes support in (tracking) tool development, oversight of its use and/or optimization (if/when relevant), or support in implementation and maintenance of regulatory IT system related projects. Key Responsibilities: 1. Core responsibilities in at least one of the three areas: a. Together with a cross-site and functional project team ensure a global harmo-nized and efficient process for submission documents, e.g. COPPs, QP declara-tion, GMP/ ML , Samples. Make sure that documents and/or samples are ordered, tracked and delivered in time and according to the requirements of the ordering function. Ensure timely communication with the ordering function and other stakeholders, as relevant. b. Support the creation and maintenance of business processes in the area of Regulatory IT systems. Act as the contact person for local Regulatory functions in case of problems in the area of IT systems or process related issues. In close cooperation with Regu-latory Operations ITSyS and IT ensure timely trouble shooting. In close cooperation with Regulatory Operations ITSyS support IT system pro-jects in all phases such as configuration, migration, system validation and roll-out. Responsible for development of new/updated business processes, user re-quirements etc. 2. Develop and maintain good working relationships with relevant RA, non-RA stakeholders and - when relevant - Health Authorities. 3. Support creation and / or maintenance of relevant training materials, work instructions and SOPs. Make sure that documentation is archived according to given rules Diversity & Inclusion / EEO We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Minimum Requirements . Basic knowledge of Regulatory Affairs processes . Preferably some experience in one of the following areas: handling of samples and/or submission documents OR resource submission planning OR electronic document management, electronic publishing, database administration. . Good expertise in organization and planning of tasks. . Experience in working in international environment. . Advanced computer skills, problem solution oriented, quality-conscious. . Good communication skills. Why Sandoz 500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while we\'re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world. How will we do this We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what\'s possible, when we collaborate with courage to aggressively and ambitiously tackle the world\'s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Sandoz!

foundit