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Director, Regulatory Project Management

Ultragenyx
  • US
    Novato, California, United States
  • US
    Novato, California, United States

Über

Position Summary We are looking for an experienced Director, Regulatory Project Manager to support the execution of regulatory strategies within the Global Regulatory Affairs function, with a specific focus on regulatory filing activities, project management tools and processes, and communication. You will translate global regulatory strategies into executable submission plans and apply your project management expertise to drive our rare disease pipeline into patients’ hands across a broad portfolio of early‑ and late‑stage development programs and marketed products.
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 filing subteams and operations, coordinating prioritization and tracking of regulatory activities for development and post‑marketing programs.
Develop and maintain high‑level and detailed regulatory timelines using project management software, ensuring alignment with global program strategies.
Resolve submission execution issues by managing contingency plans and coordinating with cross‑functional stakeholders to mitigate delays.
Track functional submission milestones (Regulatory, CMC, Clinical, Nonclinical) and maintain overall adherence to timelines.
Identify risks and mitigation strategies, enhancing consistency and efficiency across programs in the Ultragenyx portfolio.
Develop and maintain program and portfolio‑level reports and dashboards to document and communicate regulatory milestones, progress, delays, risks, and issues.
Facilitate regulatory filing team and working group meetings, including scheduling, preparing documentation, agendas, minutes, and follow‑up on action items.
Support the development, implementation, and continuous improvement of global regulatory business processes, tools, templates, dashboards, analytics, and project management practices.
Requirements
Bachelor’s or higher degree in a related field with 8–10+ years of regulatory project management, (bio)pharmaceutical project management, or a related discipline; PMP certification a plus.
Working knowledge of global regulatory agency regulations, guidelines, and submissions across nonclinical, clinical, and CMC (bio)pharmaceutical drug/product development.
Direct experience managing original Marketing Applications and/or LCM submissions from creation to submission through approval/post‑approval.
Exceptional project management and organizational skills, with demonstrated ability to prioritize and manage multiple tasks simultaneously under tight timelines in a cross‑functional environment.
Strategic thinking focused on regulatory strategy execution and global process improvement, with a passion for novel project management tool development.
Highly proficient in Smartsheet, Microsoft Project, or other scheduling tools, applying best practices for WBS, timelines, and critical path; experience with One Pager and Veeva Vault RIM is a plus.
Will travel to Ultragenyx’s offices or other locations on occasion, as needed.
Salary and Benefits Salary Range:
$217,000 USD – $268,100 USD (annual), with eligibility for annual bonus and equity incentives.
Benefits include:
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
Equal Opportunity Employment 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 talentacquisition@ultragenyx.com.
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  • Novato, California, United States

Sprachkenntnisse

  • English
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