Global Regulatory Affairs Leader, Diagnostics

Roche Holding AG; Indianapolis (IN); On-site; USD 347,000 - 455,000; Full time

Benefits offered by this job

Relocation benefits

Discretionary annual bonus

Job summary

Roche in Indianapolis seeks a Global Head of Regulatory Affairs to lead global registrations across regions, embedding VACC leadership and driving high-quality submissions. You will collaborate with the Diagnostics Solutions leadership team to enable global access to our product portfolio and maintain Roche’s industry-leading position.

The role requires extensive regulatory experience, cross‑functional leadership, and a track record in US FDA interactions and global dossiers.

Qualifications

• 15+ years of regulatory management experience in international and US arenas.
• Experience in Dia or MedTech or both is preferred.
• Proven record in filings (510ks, PMAs, IDEs) and global dossiers.
• Strong leadership in a matrix or enterprise-level environment.
• Experience leading diverse, global teams and managing budgets.

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 regulatory bodies; liaise with Affiliates.
• Ensure timely registration data and dossiers for rapid patient access to products.
• Drive standardization of regulatory processes and submissions strategies.
• Inspire and develop the RA team in line with Roche values and Diagnostics culture.
• Manage resources and foster agile ways of working for high-quality submissions.

Skills

Regulatory leadership

Global regulatory submissions

FDA interactions

Stakeholder management

Education

University degree in a relevant field

Post-graduate qualification preferred

Job description

Roche in Indianapolis seeks a Global Head of Regulatory Affairs to lead global registrations across regions, embedding VACC leadership and driving high-quality submissions. You will collaborate with the Diagnostics Solutions leadership team to enable global access to our product portfolio and maintain Roche’s industry-leading position.

The role requires extensive regulatory experience, cross‑functional leadership, and a track record in US FDA interactions and global dossiers.