Contract Associate, Regulatory Affairs, LATAM

at  Ultragenyx Pharmaceutical

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, Regulatory Affairs LATAM will be responsible for providing support for all regulatory aspects for MAA and LCM for marketed and new 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 drugs and biologics in all phases of development. Excellent verbal and written communication skills in English and Spanish are required. Portuguese is a plus. The Associate, Regulatory Affairs LATAM will be based Colombia, Bogota.

REQUIREMENTS:

• Pharmacy degree or BA/BS degree in life sciences.
• Experience in Regulatory Affairs in the pharmaceutical industry is desirable.
• Outstanding verbal, written and interpersonal communication skills in English and Spanish. Knowledge of Portuguese 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 INVIMA and/or LATAM drug registration regulations and guidelines; Knowledge of foreign regulations and ICH is a plus.
• Knowledge of orphan drug development is a plus.
• Knowledge of biologics requirements 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.
• Experience working with external regulatory consultants is a plus.
• PC literacy required; proficient use of technology including MSOffice skills (Outlook, Word, Excel, Powerpoint, EDMS, Power BI, and Internet resources is expected). #LI-CK1 #LI-Hybrid

• 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 LATAM 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 drugs and biologics in all phases of development, as well as knowledge of therapeutic area.