Global Head of Regulatory Strategy, Diagnostics

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

Benefits offered by this job

Relocation benefits

Discretionary annual bonus

Job summary

Roche seeks a Global Head of Regulatory Affairs to lead global regulatory registrations and enable access to diagnostics solutions worldwide. You will build and guide a high-performing RA team, collaborate with the Diagnostics Solutions leadership, and drive strategies across Europe, US and APAC with a focus on quality and speed.

You bring 15+ years in regulatory management, strong leadership in matrix environments, and proven expertise with FDA and global regulators, aiming to position Roche

Qualifications

• Progressive regulatory leadership experience in international and US arenas.
• Experience in Dia or MedTech or both, with IVD filings knowledge.
• Strong record in leading regulatory submissions and strategy.
• Budget ownership and team development experience.

Responsibilities

• Provide strategic direction for global regulatory submissions across regions.
• Serve as regulatory point of contact with US FDA and other agencies.
• Ensure timely registration data and dossiers for global access.
• Monitor regulatory environments and assess impact of changes.
• Develop best-in-class regulatory processes and submission strategies.
• Lead a matrixed regulatory team with strong stakeholder relationships.
• Manage RA resources, budgets, and QMS registration modules.
• Deliver on registration milestones in lifecycle teams and affiliates.
• Grow technical capabilities and knowledge management within RA.

Skills

Regulatory leadership

Stakeholder management

Matrix leadership

Strategic direction

Global regulatory knowledge

FDA/regulatory negotiations

People development

Change management

Communication skills

Budget management

Negotiation with regulators

Visionary leadership

Innovation mindset

Global team building

Education

University degree in a relevant field

Post-graduate qualification (MSc; MBA; or higher)

Tools

QMS modules

IT systems

Job description

Roche seeks a Global Head of Regulatory Affairs to lead global regulatory registrations and enable access to diagnostics solutions worldwide. You will build and guide a high-performing RA team, collaborate with the Diagnostics Solutions leadership, and drive strategies across Europe, US and APAC with a focus on quality and speed.

You bring 15+ years in regulatory management, strong leadership in matrix environments, and proven expertise with FDA and global regulators, aiming to position Roche