Ultragenyxpharmaceutical

Associate Director, Regulatory Project Manager

United States - Remote · Director · Full-time

Sponsorship not specifiedDetected 13 hours ago
Project ManagementProcess ImprovementFDA RegulatoryLeadershipCommunicationOrganizational SkillsRegulatory Affairs

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16Unrated
Cap-exempt (no lottery)0
Sponsors this role0
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70

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About the role

  • ultra dedicated - Your biggest challenges yield rare possibilities
  • We'll look to you to translate global regulatory strategies into meaningful, executable submission plans, applying your project management expertise to assist us in driving our pipeline of rare disease programs into the hands of patients.
  • You'll be working on an exciting portfolio across broad therapeutic areas and modalities in both early and late-stage development programs as well as marketed products, with plenty of opportunities to broaden your experience and advance your career.

Responsibilities

  • Partner with Regulatory leads to manage regulatory filing sub teams and sub team operations, including the coordination, prioritization, and tracking of regulatory activities associated with Ultragenyx's development and post-marketing activities
  • Develop and maintain high level and detailed regulatory timelines that utilize project management software tools, with input from functional leads, cross-functional teams, and senior management, assuring that regulatory timelines are aligned with global program strategies
  • Identify risks and mitigation strategies as well as opportunities for consistency and efficiency across programs in the Ultragenyx portfolio to most effectively support global regulatory pathways
  • Develop and maintain program- and portfolio-level reports and dashboards to document and facilitate regulatory milestone and submission communications and ensure that all stakeholders are informed and knowledgeable of activities, progress /delays, and risks / issues
  • Support the development, implementation, and continuous improvement of global regulatory business processes, tools, templates, dashboards, analytics, and regulatory project management practices

Requirements

  • Working knowledge of global regulatory agency regulations, guidelines, and submissions and nonclinical, clinical, and CMC (bio)pharmaceutical drug / product development
  • meeting leadership and discussion facilitation experience required )

Nice to have

  • PMP certification a plus
  • 8 years of experience in regulatory project management, (bio)pharmaceutical project management, and/or related discipline
  • Bachelor's or higher degree in a related field with > 5.

Benefits

  • 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 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.

Company info

  • 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.
  • 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.
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