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Associate Director, Regulatory Project Manager

Job in Boise, Ada County, Idaho, 83701, USA
Listing for: Ultragenyx Pharmaceutical
Full Time position
Listed on 2026-10-01
Job specializations:
  • Healthcare
    Healthcare Management
Salary/Wage Range or Industry Benchmark: 194000 - 240000 USD Yearly USD 194000.00 240000.00 YEAR
Job Description & How to Apply Below

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:

_ ultra dedicated – Your biggest challenges yield rare possibilities_

We are looking for an Associate

Director, Regulatory Project Manager to support the execution of regulatory strategies within the Global Regulatory Affairs function with specific focus on regulatory filing activities, project management tools and processes, and communication.

We’lllook to you to translate global regulatory strategies into meaningful, executable submission plans, applying your project managementexpertisetoassistus in driving our pipeline of rare disease programs into the hands of patients.

You’llbe working on an exciting portfolio across broad therapeutic areas and modalities in both early andlate-stage development programs as well as marketed products, with plenty of opportunities to broaden your experience and advance your career.

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:
  • Partner with Regulatory leads to manage regulatory filingsub teamsandsub team operations, including the coordination, prioritization, and tracking of regulatory activities associated with Ultragenyx’s development and post-marketing activities
  • Develop andmaintainhigh leveland detailed regulatory timelines thatutilizeproject management software tools, with input from functional leads, cross-functional teams, and senior management, assuring that regulatory timelines are aligned with global program strategies
  • Resolve submission execution issues by managing contingency plans with cross-functional stakeholder input and resolving delays or potential delays
  • Track functional submission milestones (Regulatory, CMC, Clinical, Nonclinical) and regulatory / submission team activities to ensure overall adherence to timelines
  • Identify risks and mitigation strategies as well as opportunities for consistency and efficiency across programs in the Ultragenyx portfolio tomost effectively support global regulatory pathways
  • Develop andmaintainprogram- and portfolio-level reports and dashboards to document andfacilitateregulatory milestone and submission communications and ensure that all stakeholders are informed and knowledgeable of activities, progress /delays, and risks / issues
  • Facilitate regulatory filing team and working group meetings (schedule, prepare /distribute documentation, prepare agendas and meeting minutes, ensure action…
  • Position Requirements
    10+ Years work experience
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