Vaga de Designer

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Stellenbeschreibung the opportunity: reporting to the general manager of csl vifor brazil, as the brazil regulatory affairs head, senior manager you will represent vifor global regulatory in brazil by providing support to the global gra project team and local affiliate with the preparation of the regulatory submissions, and supporting global regulatory affairs in the development and monitoring of long- And short-Term product regulatory planning related to new registration and life cycle management in brazil. You will also develop and evaluate registrations strategies to ensure effective achievement of regulatory/business objectives, approvals, and optimal labels. You will monitor national registration requirements through reviews of websites, publications, seminars, and similar sources, and communicate requirements to gra and local staff, as well as proactively address industry trends and opportunities, and key regulatory trends related to registration requirements supporting new product approval. This is a hybrid role, which requires some onsite work . The role: support the compilation, submission and maintenance of nda, in alignment with ra international strategy. Review and approve product information, customer medicine information, labels and other documentation as required for local regulatory compliance. Act as primary vifor ra representative in front of the anvisa (qp or deputy qp in the future. Interact with local ra partners and / or local health authorities to drive regulatory activities approval. Develop advocacy, support authority management with stakeholder mapping and proactively build and strengthen external stakeholder contacts (external experts, industry organizations, etc.) in brazil. Contribute to development of vifor local regulatory procedures and policies, including adapting global templates to local affiliate needs. Maintain gra archiving and tracking systems with local documents to ensure easy and quick access to all documents and transparenc