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← Ultragenyx Pharmaceutical

Associate Director, Regulatory Operations, EMEA

Ultragenyx Pharmaceutical
Location
Basel, Switzerland
Posted
24 days ago
Department
Global Regulatory Affairs
What they actually want (must-haves)
  • Bachelor's degree in a scientific, technical, or related discipline, or an equivalent combination of education and relevant experience
  • Minimum of 8 years of Regulatory Operations experience within the pharmaceutical, biotechnology, or related life sciences industry
  • Extensive knowledge of global regulatory submission requirements, formats, processes, standards, specifications, and health authority expectations
  • Demonstrated ability to operate as both a Submission Manager and Publisher across complex global regulatory submissions
  • Strong communication, stakeholder engagement, and project leadership skills with the ability to influence, collaborate, and drive alignment across functions and organizational levels
  • Exceptional attention to detail, critical thinking, and problem-solving skills, with a demonstrated commitment to quality and compliance
Nice to have
  • Experience with eCTD 4.0 submissions, pilot programs, testing initiatives, implementation activities, or transition planning is highly desirable
What the job really is

The Associate Director of Regulatory Operations at Ultragenyx will lead regulatory submission planning and execution for EMEA, ensuring high-quality submissions to health authorities. The role requires collaboration with various stakeholders, management of publishing activities, and oversight of compliance with regulatory standards. The position also involves driving transformation initiatives and adapting to evolving regulatory landscapes, emphasizing technology and process optimization.

Benefits
  • 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
Things to weigh
  • No salary listed
  • Role requires a hybrid work model with onsite work 2-3 days a week
  • Focus on transformation and technology may imply a fast-paced and evolving work environment
Job score3.6/5
Benefits4/5
Freshness4/5
Career value5/5
Role clarity5/5
Pay transparency0/5

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