Core Lab Regulatory Affairs Network Lead

F. Hoffmann-La Roche AG; Indianapolis (IN); On-site; USD 200,000 - 371,000; Full time

Job summary

Roche, a global leader in diagnostics, seeks a Core Lab Network Lead to drive regulatory strategies and submissions across the Core Lab portfolio. You will translate customer needs into priorities and work with Functional Partners and Squads to deliver high-quality dossiers and registrations.

Based in a global role, you will foster agile ways of working and ensure regulatory readiness across regions, enabling rapid patient access to diagnostics solutions.

Qualifications

• 10+ years in Regulatory Affairs within diagnostics industry or related field.
• Knowledge of IVD, Pharmaceutical, or Medical Device regulatory requirements.
• Experience with global submissions for US FDA, EU Notified Bodies, and international regions.

Responsibilities

• Lead and translate customer and business needs into regulatory priorities.
• Drive development of global regulatory strategies and dossiers.
• Collaborate across networks to deliver regulatory plans and ensure timely submissions.
• Balance compliance with innovative approaches to meet customer needs.

Skills

Regulatory affairs experience

Strategic thinking

Education

Science degree (Bachelor or Advanced)

Job description

Roche, a global leader in diagnostics, seeks a Core Lab Network Lead to drive regulatory strategies and submissions across the Core Lab portfolio. You will translate customer needs into priorities and work with Functional Partners and Squads to deliver high-quality dossiers and registrations.

Based in a global role, you will foster agile ways of working and ensure regulatory readiness across regions, enabling rapid patient access to diagnostics solutions.