Global Regulatory Chief, Diagnostics Solutions

F. Hoffmann-La Roche AG; Indianapolis (IN); Sur place; USD 347 000 - 455 000; Plein temps

Avantages offerts par ce poste

Relocation benefits

Discretionary annual bonus

Résumé du poste

Roche is seeking a Global Head of Regulatory Affairs to lead global regulatory submissions and registrations, partnering with regional heads to enable worldwide access to diagnostic solutions. The role emphasizes VACC leadership, budget management, and matrix leadership across Europe, US, and APAC.

Indianapolis is the primary location with relocation benefits possible. The candidate will oversee resource allocation, QA modules for registration, and timely product registrations to lifecycle teams

Qualifications

• 15+ years regulatory management experience in international and US arenas.
• Experience in Dia or MedTech and IVD with filings (510k, PMA, IDEs).
• Proven leadership in global, matrixed organizations.

Responsabilités

• Provide strategic direction for global regulatory submissions.
• Coordinate with US FDA and other regulators.
• Ensure timely registration data availability across affiliates.
• Drive best-in-class regulatory processes and submission strategies.
• Foster agile mindset and high-quality submissions.

Connaissances

Regulatory leadership

FDA negotiations

Global registrations

Budget management

Formation

University degree in relevant field

MBA or MSc preferred

Outils

QMS systems

IT systems

Description du poste

Roche is seeking a Global Head of Regulatory Affairs to lead global regulatory submissions and registrations, partnering with regional heads to enable worldwide access to diagnostic solutions. The role emphasizes VACC leadership, budget management, and matrix leadership across Europe, US, and APAC.

Indianapolis is the primary location with relocation benefits possible. The candidate will oversee resource allocation, QA modules for registration, and timely product registrations to lifecycle teams