Why join us? be a hero for our rare disease patients at ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. to achieve this goal, our vision is to lead the future of rare disease medicine. for us, this means going where other biopharma companies won't go - challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. we do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. our commitment and care for patients extends to our people, so culture is an essential cornerstone for ultragenyx. we remain continuously focused on creating a supportive and inclusive environment of profound learning and growth - so employees can thrive in all areas of their lives, in and outside of work. ultimately, we want to be an organization where we would be proud for our family, friends and children to work. if you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team. position 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. the manager will work closely with regional and global regulator...
**why join us?** - be a hero for our rare disease patients_ our commitment and care for patients extends to our people, so culture is an essential cornerstone for ultragenyx. we remain continuously focused on creating a supportive and inclusive environment of profound learning and growth - so employees can thrive in all areas of their lives, in and outside of work. ultimately, we want to be an organization where we would be proud for our family, friends and children to work. if you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team_. _ **position 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. the manager will work closely with regional and global regulatory colleagues, functional areas, and project teams to support regulatory activities in the latin america region. the individual must possess knowledge of global rules, regulations, and guidance's governing the commercialization and development of drugs and biologics in all phases. the manager, regulatory affairs, latam will be based bogota, colombia with hybrid model requiring 3 days-office. the position will be hired with a contract through michael page-colombia. **_ ultra_**_innovative - tackle rare and dynamic challenges_ **work model**: flex: this role will typically require onsite work 2-3 days each week, or more depending on business needs. in many locations, the busin...
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 sl...
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