Regulatory Affairs Subchapter Lead – Diagnostics

Roche; Rotkreuz; Vor Ort; CHF 90.000 - 210.000; Vollzeit

Benefits dieser Stelle

Discretionary annual bonus

Zusammenfassung

Roche is seeking a Senior Regulatory Affairs Leader to guide a global team across regulatory strategy, submissions, and lifecycle management. You will mentor 10–15 staff, collaborate with FDA and international regulators, and drive standardized processes while promoting Agile leadership and cross-functional partnerships.

Based in the global organization, this role emphasizes strategic thinking, stakeholder management, and sustained regulatory excellence to enable Roche Diagnostics’ access to

Qualifikationen

• Bachelor or advanced degree in science or related field.
• 7+ years of Regulatory Affairs experience in diagnostics/related field.
• Experience with global regulatory submissions (FDA, Notified Bodies, global).

Aufgaben

• Lead and coach 10–15 Regulatory Affairs staff.
• Act as SME with US FDA, Notified Bodies, and international regulators.
• Manage resources across teams and drive standardization of processes.
• Model Agile Leadership and champion new ways of working.
• Foster cross-functional collaboration and consensus-building.

Kenntnisse

Regulatory leadership

Stakeholder management

Strategic thinking

Verbal and written communication

Ausbildung

Bachelor or Advanced degree in science

Jobbeschreibung

Roche is seeking a Senior Regulatory Affairs Leader to guide a global team across regulatory strategy, submissions, and lifecycle management. You will mentor 10–15 staff, collaborate with FDA and international regulators, and drive standardized processes while promoting Agile leadership and cross-functional partnerships.

Based in the global organization, this role emphasizes strategic thinking, stakeholder management, and sustained regulatory excellence to enable Roche Diagnostics’ access to