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:
ultraimpact – Make a difference for those who need it most
The Associate II, Regulatory Affairs LATAM will be responsible for providing support for all regulatory aspects for MAA and LCM for marketed and new products; and CTA for pipeline products. The responsibilities include support for preparation of a variety of regulatory submissions and working closely with functional areas and project teams. In addition, support to administrative and project management activities as well as keep the regulatory systems up to date. The individual must possess basic knowledge of rules, regulations, and guidances governing synthetic products (small molecules) and biological products in all phases of development. Any level of experience with Gene Therapies is a plus. Excellent verbal and written communication skills in Portuguese and English are required. Spanish is a plus. The Associate II, Regulatory Affairs LATAM will be based São Paulo, Brazil.
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 business will set certain days each week that Flex employees are required to be onsite.
Responsibilities:
- Assist with the development of basic regulatory documents to ensure we meet the health authority requirements for submissions of high quality.
- Assist with creating and maintaining regulatory timelines and tracking deliverables to ensure regulatory submission timelines are met.
- Assist in drafting application forms, cover letters, coordinating translations, creation of content plan and archival in Veeva RIM of final submissions and correspondence, etc.
- Assist in drafting meeting minutes, request quotations, request/follow up to contract process, develop and keep trackers and regulatory databases.
- Assist with requesting Health Authority meetings, as necessary to support regulatory filings and applications.
- Support the local regulatory team in all activities related to setting up SOPs, procedures, and databases for the department.
- Support timely update of the regulatory affairs filings tracking system for LATAM correspondence with the authorities.
- Maintain knowledge of current regulations and guidances governing synthetic products (small molecules), biological products and gene therapies in all phases of development, as well as knowledge of therapeutic area.
Requirements:
- Bachelor’s degree in Pharmacy.
- Experience in Regulatory Affairs in the pharmaceutical industry is desirable.
- Outstanding verbal, written and interpersonal communication skills in Portuguese and English. Knowledge of Spanish is a plus.
- Motivated, self-starter, and able to work independently with supervision and in a team environment.
- Must be highly motivated, curious, and eager to learn/apply new skills.
- Demonstrated ability to prioritize multiple tasks simultaneously.
- Demonstrated understanding of ANVISA’s synthetic products (small molecules) and biological products registration regulations and guidelines; Knowledge of foreign regulations and ICH is a plus.
- Knowledge of orphan drug development is a plus.
- Knowledge of gene therapies requirements is a plus.
- Knowledge of Clinical Trial Applications (DDCM and DDCTA) is a plus.
- Interest in working in a growing biotech company, partnering with the members of regulatory team and regional/global teams to overcome the challenges and develop solutions.
- PC literacy required; proficient use of technology including MS Office skills (Outlook, Word, Excel, Powerpoint and Internet resources is expected).
- EDMS and Power BI skills are a plus. #LI-CK1 #LI-Hybrid
Full Time employees across the globe enjoy a range of benefits, including, but not limited to:
· Generous vacation time and public holidays observed by the company
· Volunteer days
· Long term incentive and Employee stock purchase plans or equivalent offerings
· Employee wellbeing benefits
· Fitness reimbursement
· Tuition sponsoring
· Professional development plans
* Benefits vary by region and country
Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and related medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact Talent Acquisition by emailing us at talentacquisition@ultragenyx.com.
Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to
: talentacquisition@ultragenyx.com. •
Last updated on Aug 27, 2024