Regulatory Affairs Subchapter Lead — Lab Diagnostics

Roche Holding AG; Indianapolis (IN); On-site; USD 111,000 - 259,000; Full time

Job summary

Roche Holding AG in Indianapolis seeks a Lab Coagulation and Clinical Chemistry II Subchapter lead to guide regulatory capabilities and staff development. You will coordinate with global regulators and drive strategic regulatory initiatives across the subchapter to meet network priorities.

You will lead 10–15 staff, manage resources, and promote Agile leadership while collaborating across Squads and Chapters in a dynamic, global environment.

Qualifications

• Bachelor or advanced degree in science or related field.
• 7+ years of Regulatory Affairs experience in diagnostics or related industries.
• Experience with US FDA, EU Notified Bodies, and international submissions.

Responsibilities

• Lead and coach 10–15 Regulatory Affairs staff to deliver high impact.
• Serve as SME with US FDA, Notified Bodies and other regulatory bodies.
• Oversee resource management and drive process standardization.
• Model Agile Leadership and cross-functional collaboration.
• Build networks and lead in a fast-changing organization.

Skills

Regulatory affairs leadership

Regulatory compliance

Stakeholder management

Agile leadership

Education

Bachelor's or Advanced degree in science

Job description

Roche Holding AG in Indianapolis seeks a Lab Coagulation and Clinical Chemistry II Subchapter lead to guide regulatory capabilities and staff development. You will coordinate with global regulators and drive strategic regulatory initiatives across the subchapter to meet network priorities.

You will lead 10–15 staff, manage resources, and promote Agile leadership while collaborating across Squads and Chapters in a dynamic, global environment.