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Position Summary:
ultradedicated – Your biggest challenges yield rare possibilities
We are looking for an experienced Director, Regulatory Project Manager to support theexecution of regulatory strategies within the Global Regulatory Affairs function with specificfocus on regulatory filing activities, project management tools and processes, andcommunication. We’ll look to you to translate global regulatory strategies into meaningful,executable submission plans, applying your project management expertise to assist us indriving our pipeline of rare disease programs into the hands of patients. You’ll be working onan 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 tobroaden 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 filing subteams and subteamoperations, including the coordination, prioritization, and tracking of regulatoryactivities associated with Ultragenyx’s development and post-marketing activities
- Develop and maintainhigh level and detailed regulatory timelines that utilize projectmanagement software tools, with input from functional leads, cross-functional teams,and senior management, assuring that regulatory timelines are aligned with globalprogram 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) andregulatory / submission team activities to ensure overall adherence to timelines
- Identify risks and mitigation strategies as well as opportunities for consistency andefficiency across programs in the Ultragenyx portfolio to most effectively support globalregulatory pathways
- Develop and maintain program- and portfolio-level reports and dashboards todocument and facilitate regulatory milestone and submission communications andensure 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 itemfollow-up; meeting leadership and discussion facilitation experience required)
- Support the development, implementation, and continuous improvement of globalregulatory business processes, tools, templates, dashboards, analytics, and regulatoryproject management practices
Requirements:
- Bachelor’s or higher degree in a related field with >8-10 years of experience inregulatory project management, (bio)pharmaceutical project management, and/orrelated discipline; PMP certification a plus
- Working knowledge of global regulatory agency regulations, guidelines, andsubmissions and nonclinical, clinical, and CMC (bio)pharmaceutical drug / productdevelopment
- Direct hands-on experience managing original Marketing Applications and/or LCMsubmissions from creation to submission through approval / post-approval
- Exceptional project management and organizational skills are required, withdemonstrated ability to prioritize and manage multiple tasks and projects to achieveprogram and department goals under tight timelines in a cross-functional environmentthat values both speed and quality
- Demonstrated capacity for strategic thinking with a focus on regulatory strategyexecution and global process improvement and optimization and passion for novelproject management tool building
- Highly proficient with using Smartsheet, Microsoft Project, or other project schedulingtool(s) in conjunction with best practices for project scheduling techniques such asmanaging WBS, timelines, and critical path; direct experience with OnePager and VeevaVault RIM is a plus
- Travel to Ultragenyx's offices or other locations on occasion, as needed.
The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicant's geographic location.
This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
· Volunteer days
· Employee wellbeing benefits
· Fitness reimbursement
· Tuition sponsoring
· Professional development plans
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 us at talentacquisition@ultragenyx.com.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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