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Senior Manager / Associate Director, Regulatory Project Management Operations

Company: Ultragenyx Pharmaceutical
Location: Novato
Posted on: May 3, 2021

Job Description:

Senior Manager / Associate Director, Regulatory Project Management Operations

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 wont 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 Outbreak,we are committed to our hiring process. The health and safety of our employees and prospective employees take priority which means at this time ourapproachwill includevideo discussions, interviews, andonboarding.

Position Summary:

ultracurious Apply your biggest ideas in courageous ways

Ultragenyx is looking for a professional Associate Director, Regulatory Project Management Operations to support the execution of regulatory strategies within the Global Regulatory Affairs function. Well look to you to translate 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 globally. Youll be working on an exciting portfolio across broad therapeutic areas and modalities in both early and late stage development programs and marketed products with plenty of opportunities to broaden your experience and advance your career.

Responsibilities including, but not limited to:

  • Partner with Regulatory leads to manage Regulatory subteams and subteam operations, including the coordination, prioritization, and tracking of regulatory activities and submissions associated with the companys development and post-marketing activities
  • Track functional submission milestones (CMC, Clinical, Nonclinical, Regulatory, ROW) and Regulatory subteam activities to ensure overall adherence to program timelines
  • Identify risks and mitigation measures as well as areas of consistency and efficiency across all programs in the Ultragenyx portfolio to most effectively and efficiently support global regulatory approval pathways
  • Resolve submission execution issues by managing contingency planning and influencing risk mitigation strategies with input from various functions and resolution of delays or potential delays
  • Facilitate Regulatory team and strategy meetings (schedule, prepare / distribute documentation, prepare agendas and meeting minutes, ensure action item follow-up; meeting leadership experience required)
  • Develop and maintain program- and portfolio-level dashboards to document and facilitate submission communications to ensure that all submission stakeholders are fully informed and knowledgeable of submission activities, progress, and risks / issues
  • 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 the global program strategy
  • Liaise with other program managers to manage timely execution of overall program strategies
  • Support the development, implementation, and continuous improvement of global regulatory business processes, tools, templates, dashboards, analytics, and regulatory project management practices
  • Respond to changing duties as responsibilities may vary based on potential pipeline growth, project needs, and stages of development (pre-clinical, clinical, or commercial)

Requirements:

  • Bachelors or Masters degree in a related field with 6-8 years experience in Regulatory project management, (bio)pharmaceutical project management, and/or related discipline
  • Working knowledge of (bio)pharmaceutical drug / product development, global Regulatory Agency regulations, guidelines, and submissions
  • Demonstrated capacity for strategic thinking with a focus on program strategy execution and global process improvement and optimization
  • Direct experience managing original Marketing Applications and/or LCM submissions from submission to approval
  • Exceptional project management and organizational skills with demonstrated ability to prioritize and manage multiple projects with tight timelines in a cross-functional environment that values speed is required
  • Proven or demonstrated ability to balance multiple tasks to achieve program and corporate goals and to efficiently meet deadlines and stakeholder expectations on-time and with high quality
  • Proficient with using Microsoft Project, Smartsheet, or other project scheduling tool(s) in conjunction with best practices for project scheduling techniques such as managing WBS, timelines, and critical path; experience with Oracle Primavera and OnePager a plus
  • Direct experience with Veeva Vault RIM a plus
  • Creative / Innovative Able to develop new and unique ways to improve and streamline processes
  • Effective Communicator Speak, listen and write in a clear, thorough and timely manner using appropriate and effective communication tools and techniques; able to respond to common inquiries or complaints from team members
  • Collaboration Experience working within a cross-functional team environment
  • Team player Work cooperatively and effectively with others to set goals, resolve problems, and make decisions which are timely and in the best interests of the organization
#LI-CS2

#LI-1

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 contactTalent Acquisitionby calling:(415) 483-8800or byemailingus attalentacquisition@ultragenyx.com . For electronic email and mail inquiries, please include a description of your requested accommodation, your name and contact information.

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 .

Keywords: Ultragenyx Pharmaceutical, Novato , Senior Manager / Associate Director, Regulatory Project Management Operations, Other , Novato, California

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