Ultragenyx Pharmaceutical Inc.
Senior Manager/Associate Director, Regulatory Project Management
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. During the COVID-19 pandemic, we are committed to the health and safety of our employees and prospective employees, which means at this time our interview processes may include virtual discussions, interviews, and onboarding. Please note that compliance with local regulations and safety protocols is a condition of employment at Ultragenyx. Elements of safety protocols may include, but are not limited to: work from home requirements, regular or symptom-based covid testing, providing valid evidence of vaccination, mask wearing, and physical distancing.
US based roles: Full vaccination against COVID-19 is a condition of employment at Ultragenyx. This requirement applies to almost all roles at Ultragenyx based in the U.S., with very limited exceptions. If you are unable to receive a COVID-19 vaccine due to a disability, serious medical condition, or because it would violate your sincerely held religious belief, you will have an opportunity to request a reasonable accommodation.
Roles based outside the US: If the role requires travel to the US or another country that requires evidence of covid vaccination for entry, candidates and employees will be required follow the local regulations and corporate policy regarding vaccination evidence submission.
Position Summary:
We are looking for a professional Senior Manager / Associate Director, Regulatory Project Management to support the execution of regulatory strategies within the Global Regulatory Affairs function. 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.
Work Model:
Flex: can complete work from home during the pandemic; once return to the office 2-3 days in office to be expected and established with manager
Remote: officially documented as working full time from home, with travel to Ultragenyx's offices or other location on occasion as needed
Responsibilities:
- Partner with Regulatory leads to manage regulatory subteams and subteam operations, including the coordination, prioritization, and tracking of regulatory activities and submissions 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
- 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 to most effectively support global regulatory pathways
- Resolve submission execution issues by managing contingency plans with cross-functional stakeholder input and resolving delays or potential delays
- 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 fully informed and knowledgeable of activities, progress / delays, and risks / issues
- Facilitate regulatory team and working group meetings (schedule, prepare / distribute documentation, prepare agendas and meeting minutes, ensure action item follow-up; meeting leadership and discussion facilitation experience required)
- Support the development, implementation, and continuous improvement of global regulatory business processes, tools, templates, dashboards, analytics, and regulatory project management practices
Requirements:
- Bachelor’s or higher degree in a related field with >4-8 years of experience in regulatory project management, (bio)pharmaceutical project management, and/or related discipline
- Working knowledge of nonclinical, clinical, and CMC (bio)pharmaceutical drug / product development and global regulatory agency regulations, guidelines, and submissions
- Direct experience managing original Marketing Applications and/or LCM submissions from creation to submission through approval / post-approval
- Exceptional project management and organizational skills are required, with demonstrated ability to prioritize and manage multiple tasks and projects to achieve program and department goals under tight timelines in a cross-functional environment that values both speed and quality
- Demonstrated capacity for strategic thinking with a focus on regulatory strategy execution and global process improvement and optimization
- Proficient with using Smartsheet, Microsoft Project, or other project scheduling tool(s) in conjunction with best practices for project scheduling techniques such as managing WBS, timelines, and critical path; direct experience with OnePager and Veeva Vault RIM is a plus
- Travel: On occasion, as needed
#LI-CS2
#LI-REMOTE
#REMOTE
Full Time employees across the globe enjoy a range of benefits, including, but not limited to:
· 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
Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status. Reasonable accommodation will be provided for qualified individuals with disabilities and for qualified disabled veterans in job application procedures, as required by applicable law. If you have any difficulty using our online application system and need an accommodation due to a disability, you may contact Talent Acquisition by calling: (415) 483-8800 or by emailing us at talentacquisition@ultragenyx.com. For electronic email and mail inquiries, please include a description of your requested accommodation, your name and contact information.
See our Privacy Policy.
Note to External Recruiters: All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Please note that failure to comply with this request will be a factor in determining a professional relationship with our organization. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Inquiries on developing a recruiting relationship with us, may be directed to: talentacquisition@ultragenyx.com.