Global Regulatory Data Ops Lead & Process Owner

Roche; Basel; Vor Ort; CHF 130.000 - 180.000; Vollzeit

Zusammenfassung

Roche seeks a Central Operations Principal to act as Business Process Owner for end-to-end safety regulatory data delivery, driving operational strategy and cross-functional execution across DSURs and PBRERs for Roche products and partnerships worldwide.

You will lead process ownership, governance, and inspection readiness; partner with Clinical Operations, Regulatory, Biometrics, Medical Affairs and Quality; and steer global PV regulatory obligations with a forward-looking, agile mindset.

Qualifikationen

• Degree in life sciences; postgraduate PV qualification preferred.
• Experience in pharmacovigilance or pharma development.
• Experience representing processes in regulatory inspections/audits.

Aufgaben

• Oversee end-to-end regulatory reporting delivery for DSURs/PBRERs.
• Lead cross-functional process improvements and governance.
• Ensure inspection readiness and regulatory compliance.
• Collaborate with Clinical Operations, Regulatory, and Quality across affiliates.
• Manage vendor relationships and monitor KPIs.

Kenntnisse

Matrix leadership

Regulatory knowledge

Cross-functional collaboration

Process optimization

PV regulatory knowledge

Ausbildung

Life sciences degree

Postgraduate qualification (PhD/MD/PharmD/MSc)

Tools

Regulatory reporting tools

Clinical databases

SDLC / validation

Jobbeschreibung

Roche seeks a Central Operations Principal to act as Business Process Owner for end-to-end safety regulatory data delivery, driving operational strategy and cross-functional execution across DSURs and PBRERs for Roche products and partnerships worldwide.

You will lead process ownership, governance, and inspection readiness; partner with Clinical Operations, Regulatory, Biometrics, Medical Affairs and Quality; and steer global PV regulatory obligations with a forward-looking, agile mindset.