Global Safety Ops Lead — Regulatory Process Owner

Roche; Welwyn; On-site; GBP 90,000 - 140,000; Full time

Job summary

Roche seeks a Central Operations Principal to drive end-to-end safety regulatory data delivery across products and partnerships. You will lead scheduling, data reconciliation, and report generation, ensuring quality and on-time delivery while aligning with PV legislation.

You will partner with Clinical Operations, Biometrics/Data Sciences, Regulatory, Medical Affairs and Quality in a global matrix, shaping process improvements and governance in a complex, international environment.

Qualifications

• Degree in life sciences (PhD/PharmD/MSc/MD or PV qualification strongly preferred).
• Substantial experience in pharmacovigilance, pharma development, or healthcare.
• Deep understanding of DSURs/PBRERs, clinical trial design/conduct/reporting, and SDLC/systems validation.
• Experience representing processes in regulatory authority inspections/audits and continual process improvement.
• Strong matrix management, negotiation, and cross-cultural collaboration in international environments.

Responsibilities

• Oversee end-to-end regulatory reporting delivery including scheduling, data reconciliation, report generation and validation.
• Lead cross-functional process improvement activities and drive reductions in cost and lead time.
• Establish robust process governance and monitor KPIs; oversee vendor delivery.
• Act as primary POC for regulatory inspections and audits; translate PV legislation into operational changes.
• Collaborate with Clinical Operations, Biometrics/Data Sciences, Regulatory, Medical Affairs and Quality at global and affiliate levels.

Skills

Regulatory reporting

Cross-functional collaboration

Leadership

Process ownership

Project management

Education

Life sciences degree

Postgraduate PV qualification

Job description

Roche seeks a Central Operations Principal to drive end-to-end safety regulatory data delivery across products and partnerships. You will lead scheduling, data reconciliation, and report generation, ensuring quality and on-time delivery while aligning with PV legislation.

You will partner with Clinical Operations, Biometrics/Data Sciences, Regulatory, Medical Affairs and Quality in a global matrix, shaping process improvements and governance in a complex, international environment.