Global Regulatory Chief for Diagnostics

Roche; Branchburg Township (NJ); On-site; USD 347,000 - 455,000; Full time

Benefits offered by this job

Relocation benefits

Discretionary annual bonus

Job summary

Roche seeks a visionary Global Head of Regulatory Affairs to lead worldwide regulatory submissions and navigate a complex, matrixed environment. You will guide strategic regulatory directions, partner with global affiliates, and drive high-impact registrations for a broad diagnostics portfolio to improve patient access.

You will manage an international team, oversee budgets, and embed VACC leadership behaviors while collaborating with senior stakeholders across Roche Diagnostics Solutions.

Qualifications

• 15+ years of progressively responsible Regulatory management experience in international and US arenas.
• Experience in Dia or MedTech or both.
• Proven track record of filings (510ks, PMAs, IDEs) and global dossiers; negotiations with US FDA.
• 5-7 years leading and managing teams and budgets.
• Post-graduate qualification (MSc/MBA or higher) preferred.

Responsibilities

• 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 regulators; coordinate with affiliates.
• Ensure timely availability of registration data and dossiers for rapid patient access.
• Drive standardized regulatory processes, submissions strategies and best practices.
• Lead and grow the RA team; manage resources and budgets; foster collaboration.

Skills

Regulatory leadership

FDA negotiations

Global regulatory filings

IVD/Diagnostics

Team leadership

Budget management

Strategic thinking

Education

University degree; MSc/MBA preferred

Job description

Roche seeks a visionary Global Head of Regulatory Affairs to lead worldwide regulatory submissions and navigate a complex, matrixed environment. You will guide strategic regulatory directions, partner with global affiliates, and drive high-impact registrations for a broad diagnostics portfolio to improve patient access.

You will manage an international team, oversee budgets, and embed VACC leadership behaviors while collaborating with senior stakeholders across Roche Diagnostics Solutions.