Global Regulatory Leader, Diagnostics Solutions

Roche; Santa Clara (CA); Sur place; USD 347 000 - 455 000; Plein temps

Avantages offerts par ce poste

Relocation benefits

Discretionary annual bonus

Comprehensive benefits package

Résumé du poste

Roche is seeking a visionary Global Head of Regulatory Affairs to lead a high-performing team delivering global regulatory registrations for diagnostics. You will guide submissions strategy, collaborate with regional heads and regulators, and ensure access to our diagnostic portfolio for patients worldwide.

We seek a senior leader with deep IVD regulatory expertise, global team leadership, and a strong track record in navigating complex regulatory paths and budgets across regions.

Qualifications

• 15+ years of progressively responsible Regulatory management experience.
• Experience in Dia or MedTech or both.
• Track record of filings (510ks, PMAs, IDEs) and global dossiers.
• Leadership of diverse, global teams and budgets.
• Bachelor or higher degree; MSc or MBA preferred.

Responsabilités

• Provide strategic direction for Global Regulatory Submissions with leadership of teams in Europe, US and APAC.
• Act as regulatory contact with US FDA and other global regulators.
• Ensure timely availability of registration data and dossiers for rapid patient access.
• Drive best-in-class regulatory processes and submission strategies.
• Lead and develop the RA team and manage resources and budgets.

Connaissances

Regulatory leadership

Global regulatory submissions

US FDA interactions

IVD regulatory experience

Cross-functional leadership

Strategic planning

Formation

University degree in a relevant field

Post-graduate qualification (MSc/MBA) preferred

Description du poste

Roche is seeking a visionary Global Head of Regulatory Affairs to lead a high-performing team delivering global regulatory registrations for diagnostics. You will guide submissions strategy, collaborate with regional heads and regulators, and ensure access to our diagnostic portfolio for patients worldwide.

We seek a senior leader with deep IVD regulatory expertise, global team leadership, and a strong track record in navigating complex regulatory paths and budgets across regions.