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. 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. A Culture of Support and Inclusion 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. About This Opportunity We are seeking an experienced and highly motivated Contractor/Consultant-SR Manager, Regulatory Affairs LATAM who is a team player and thrives in a fast-paced, dynamic work environment. The Sr Manager will work closely with regional and global regulatory colleagues, functional areas, and project teams to support regulatory activities in the Latin America region. Responsibilities - Prepare and manage filings of regulatory marketing authorization (MA) applications in the LATAM territories, as required by the regulatory plan. - Lead assessments 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. - Lead partnerships with key stakeholders to deliver innovative 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. - Participate on 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. Requirements - Pharmacy degree preferred or BA/BS degree in life sciences. - Relevant scientific background with 6-8 years of experience in Regulatory Affairs associated roles in the biotech or pharmaceutical industries with at least three years of experience in Regulatory Affairs in the LATAM region. - The candidate must have hands-on experience with regulatory filings in at least one of the following markets: Mexico, Colombia, Argentina, Central America, or Brazil. - Strong knowledge and experience in interpretation of LATAM regulations for MAA/LCM drug registration processes. Knowledge of foreign regulations and ICH is required. - Knowledge of orphan drug/biologics products is a plus. - Experience working with external regulatory consultants is a plus. - The desire and ability to work in a fast-paced, start-up environment, eager to learn/apply new skills. - Requires initiative, able to work independently with supervision, creative problem-solving ability, hands-on willing to work, and excellent verbal and written communication skills in Spanish and English. Portuguese is a plus. - Demonstrated ability to strategize, prioritize and manage with project management skills multiple tasks simultaneously.