Job summary Ultragenyx is seeking an experienced and highly motivated Contractor/consultant-Manager, Regulatory Affairs LATAM who is a team player and thrives in a fast-paced, dynamic work environment. Responsibilities - Prepare and manage filings of regulatory marketing authorization (MA) applications in the LATAM territories, as required by the regulatory plan for the products under responsibility - Lead assessments and execution of Life Cycle Management changes to provide guidance and support to global teams by applying technical knowledge, experience and strategic solutions - Independently researches options for regulatory strategies and presents recommendations at regulatory sub teams and to leadership - Manage preparation of responses to questions from health authorities in the LATAM markets - Interface and develop partnerships with key stakeholders to deliver strategies, facilitating interactions with local partners/consultants - Creates and maintains submission schedules and timelines with regulatory operations and the cross functional team, ensuring timely delivery of high-quality documents - Support the LATAM regulatory team in all activities related to setting up SOPs, procedures, and databases for the department - Participate in cross-functional committees and sub-teams in accordance with company initiatives, as necessary - Strategic participation in trade-associations meetings as required - Support the preparation of Agency meetings as necessary to support regulatory filings and applications, including preparation and coordination of briefing packages and slide deck presentations - Support (non-)promotional material revision and approval for the LATAM markets in the system established for such activity Descripción del trabajo Lorem ipsum dolor sit amet , consectetur adipiscing elit. Nullam tempor vestibulum ex, eget consequat quam pellentesque vel. Etiam congue sed elit nec elementum. Morbi diam metus, rutrum id eleifend ac, porta in lectus. Sed scelerisque a augue et ornare. Donec lacinia nisi nec odio ultricies imperdiet. Morbi a dolor dignissim, tristique enim et, semper lacus. Morbi laoreet sollicitudin justo eget eleifend. Donec felis augue, accumsan in dapibus a, mattis sed ligula. Vestibulum at aliquet erat. Curabitur rhoncus urna vitae quam suscipit , at pulvinar turpis lacinia. Mauris magna sem, dignissim finibus fermentum ac, placerat at ex. Pellentesque aliquet, lorem pulvinar mollis ornare, orci turpis fermentum urna, non ullamcorper ligula enim a ante. Duis dolor est, consectetur ut sapien lacinia, tempor condimentum purus. Obtén acceso completo Accede a todos los puestos de alto nivel y consigue el trabajo de tus sueños. Inscríbete ahora