Senior Associate, Global Regulatory Operations - Fixed Term Contract - Remote Eligible

Senior Associate, Global Regulatory Operations - Fixed Term Contract

Netherlands - Remote; United Kingdom - Remote

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:

Ultra focused – Work together to fearlessly uncover new possibilities

Ultragenyx is seeking a highly motivated individual for the role of Senior Associate Global Regulatory Operation who will provide support for the regulatory department, ensuring efficient and compliant business processes and environment. This position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory submissions, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for submissions operations team.

Work Model:

Remote: Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed.

Responsibilities:

• Performs moderately complex to non-routine submission formatting activities associated with generating hard copy and electronic submission-ready documents and reports.
• Electronically compiles all components of moderately complex submissions using Lorenz DocuBridge™ and associated publishing tools including but not limited to: eCTDs - National and Centralized Procedures; Post Marketing/Life-cycle Management: Type Ia, Ib and II Variations & Renewals; Orphan Drug Documents, Scientific Advice and PIPs.
• Dispatches submissions through the relevant gateways/portals (e.g. EMA Submissions Gateway and US Gateway and/or other channels) and electronically archives them according to the departmental practices.
• Participates in supporting and promoting current routine electronic initiatives in moving the company forward with electronic submissions and electronic archives.
• May interface with cross-functional teams and or content authors to discuss routine submission preparation and content.
• May assist and/or provide training to others on software tools used and educating authors in publishing policies and procedures.
• Identifies and records issues that require resolution prior to finalization and liaises with the author responsible to resolve issues. Assists authors in the completion and compilation of regulatory documents to ensure all components are provided and presented in the correct format.
• Exercises judgment within well-defined procedures and practices to determine appropriate action.

Requirements:

• BA or BS degree with 3+ years of Regulatory Operations experience or an equivalent combination of education and experience preferred.
• Strong experience with EU submissions, but also some experience with submissions in other regions (US, CA, ROW, etc.)
• Experience in successfully working in a fast-paced environment with tight timelines, large deliverables.
• Ability to manage multiple ongoing projects simultaneously.
• Must have excellent verbal and written skills, very strong organizational and time management skills.
• Must have a very strong attention to detail with an ability to detect and correct errors/inconsistencies in various types of documents.
• Should demonstrate flexibility and willingness to accommodate ad-hoc requests and work effectively within an environment that has quickly changing processes, priorities and deadlines as well as to work overtime in order to meet required timelines.
• Must have a strong working knowledge and understanding of MS Word, Word templates, Adobe Acrobat, ISIToolBox, eCTD validation software, Lorenz DocuBridge (or other eCTD submission publishing tools) and standard Office tools.

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