Contractor Senior Manager, Regulatory Affairs, LATAMBogota, Colombia Why Join Us? Be a hero for our rare diseasepatients At Ultragenyx, we fundamentally believe that taking realimpactful action to care for the needs of patients and our peopleis always the right thing to do. To achieve this goal, our visionis to lead the future of rare disease medicine. For us, this meansgoing where other biopharma companies won’t go – challenging thestatus quo and creating a new model that advances our field so morepatients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapiddevelopment approach, making innovative medicines at fair andreasonable prices, and creating a collaborative ecosystem to reachpatients in ways that are most meaningful for them. Our commitmentand care for patients extends to our people, so culture is anessential cornerstone for Ultragenyx. We remain continuouslyfocused on creating a supportive and inclusive environment ofprofound learning and growth – so employees can thrive in all areasof their lives, in and outside of work. Ultimately, we want to bean organization where we would be proud for our family, friends andchildren to work. If you want to have a meaningful impact, do thebest work of your career, and grow a lot, both professionally andpersonally, come join our team. Position Summary: Ultragenyx isseeking an experienced and highly motivated SR Manager, RegulatoryAffairs LATAM who is a team player and thrives in a fast-paced,dynamic work environment. The Sr Manager will work closely withregional and global regulatory colleagues, functional areas, andproject teams to support regulatory activities in the Latin Americaregion. The individual must possess relevant knowledge of globalrules, regulations, and guidance governing the commercializationand development of drugs and biologics in all phases. The SRManager, Regulatory Affairs, LATAM will be based in Bogota,Colombia. Work Model: Flex: This role will typically require onsitework 2-3 days each week, or more depending on business needs. Inmany locations, the business will set certain days each week thatFlex employees are required to be onsite. Responsibilities: -Prepare and manage filings of regulatory marketing authorization(MA) applications in the LATAM territories, as required by theregulatory plan. - Lead assessments of Life Cycle Managementchanges to provide guidance and support to global teams by applyingtechnical knowledge, experience, and strategic solutions. -Independently research options for regulatory strategies andpresent recommendations at regulatory sub-teams and to leadership. - Manage preparation of responses to questions from healthauthorities in the LATAM markets. - Lead partnerships with keystakeholders to deliver innovative strategies, facilitatinginteractions with local partners/consultants. - Create and maintainsubmission schedules and timelines with regulatory operations andthe cross-functional team, ensuring timely delivery of high-qualitydocuments. - Participate on cross-functional committees andsub-teams in accordance with company initiatives, as necessary. -Strategic participation in trade-associations meetings as required. - Support the preparation of Agency meetings as necessary tosupport regulatory filings and applications, including preparationand coordination of briefing packages and slide deck presentations. Requirements: - Pharmacy degree preferred or BA/BS degree in lifesciences. - Relevant scientific background with 6-8 years ofexperience in Regulatory Affairs associated roles in the biotech orpharmaceutical industries with at least three years of experiencein Regulatory Affairs in the LATAM region. - The candidate musthave hands-on experience with regulatory filings in at least one ofthe following markets: Mexico, Colombia, Argentina, CentralAmerica, or Brazil. - Strong knowledge and experience ininterpretation of LatAm regulations for MAA/LCM drug registrationprocesses. Knowledge of foreign regulations and ICH is required. -Knowledge of orphan drug/biologics products is a plus. - Experienceworking with external regulatory consultants is a plus. - Thedesire and ability to work in a fast-paced, start-up environment,eager to learn/apply new skills. - Requires initiative, able towork independently with supervision, creative problem-solvingability, hands-on willing to work, and excellent verbal and writtencommunication skills in Spanish and English. Portuguese is a plus. - Demonstrated ability to strategize, prioritize and manage withproject management skills multiple tasks simultaneously. Full Timeemployees across the globe enjoy a range of benefits, including,but not limited to: - Generous vacation time and public holidaysobserved by the company - Long term incentive and Employee stockpurchase plans or equivalent offerings - Fitness reimbursement *Benefits vary by region and country Ultragenyx Pharmaceutical is anequal opportunity employer and prohibits unlawful discriminationbased on race, color, religion, gender, sexual orientation, genderidentity/expression, national origin/ancestry, age, disability,marital and veteran status, and any other status or classificationprotected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protectedstatuses or classifications protected by applicable law, includingindividuals with disabilities, disabled veterans, for pregnancy,childbirth, and related medical conditions, and based on sincerelyheld religious beliefs. Applicants can request an accommodationprior to accepting a job offer. #J-18808-Ljbffr