EMEA Regulatory Operations Lead — Submissions & Transformation

Ultragenyx; Basel; Hybrid; CHF 140.000 - 210.000; Vollzeit

Benefits dieser Stelle

Vacation time

Volunteer days

Stock purchase plan

Wellbeing benefits

Fitness reimbursement

Tuition sponsorship

Professional development

Zusammenfassung

Ultragenyx Pharmaceutical in Basel is seeking an Associate Director, Regulatory Operations (EMEA) to lead complex regulatory submissions from planning through delivery. You will drive publishing strategies, ensure data integrity, and partner across Regulatory Affairs, Global Operations, and stakeholders to enable compliant, timely submissions.

The role requires hands-on publishing expertise, strong leadership, and a track record of transforming regulatory processes in a fast-paced environment.

Qualifikationen

• Bachelor's degree in a scientific, technical, or related discipline, or equivalent experience.
• Minimum of 8 years in Regulatory Operations in life sciences.
• Extensive knowledge of global regulatory submission formats and health authority expectations.
• Experience as Submission Manager and Publisher for complex global submissions.
• Strong collaboration and program leadership across functions.

Aufgaben

• Lead end-to-end regulatory submission planning and execution for assigned programs.
• Develop and execute publishing strategies with timelines and content plans.
• Perform publishing activities including document prep, bookmarking, and eCTD submission.
• Ensure documentation accuracy and inspection-readiness across regions.
• Build partnerships to drive aligned regulatory and business objectives.
• Drive transformation and scalable improvements in Regulatory Operations.

Kenntnisse

Regulatory Operations

Submission management

Publishing

Stakeholder engagement

Project leadership

Quality/compliance focus

Ausbildung

Bachelor's degree in a scientific, technical, or related discipline

Tools

Veeva Vault RIM

Lorenz DocuBridge

StartingPoint Templates

DXC Toolbox

Adobe Acrobat Pro

SharePoint

Smartsheet

Jobbeschreibung

Ultragenyx Pharmaceutical in Basel is seeking an Associate Director, Regulatory Operations (EMEA) to lead complex regulatory submissions from planning through delivery. You will drive publishing strategies, ensure data integrity, and partner across Regulatory Affairs, Global Operations, and stakeholders to enable compliant, timely submissions.

The role requires hands-on publishing expertise, strong leadership, and a track record of transforming regulatory processes in a fast-paced environment.