Subchapter Lead, Regulatory Affairs - Lab Coagulation

Roche; Carlsbad (CA); On-site; USD 111,000 - 259,000; Full time

Benefits offered by this job

Discretionary annual bonus

Job summary

Roche seeks a Lab Coagulation and Clinical Chemistry II Subchapter lead within the Medical Value Assays chapter to guide regulatory capabilities and coach a team of SMEs. You will advance portfolio objectives with scientific rigor and regulatory insight.

The role emphasizes global submissions, regulatory strategy, and cross-functional collaboration across sites, including multiple U.S. and international locations. A discretionary bonus may apply.

Qualifications

• Bachelor or advanced degree in science or related field.
• 7+ years of Regulatory Affairs experience in diagnostics or related field.
• Experience with US FDA submissions and international regulatory bodies.

Responsibilities

• Develop and coach 10–15 Regulatory Affairs staff for impact.
• Act as SME with US FDA, Notified Bodies, and international regulators.
• Oversee resource management and drive process standardization.
• Model Agile Leadership and cross-functional collaboration.
• Navigate a changing organization with open communication and consensus.

Skills

Regulatory leadership

Stakeholder management

Global submissions

Agile leadership

Verbal and written communication

Education

Bachelor or advanced degree in science

Job description

Roche seeks a Lab Coagulation and Clinical Chemistry II Subchapter lead within the Medical Value Assays chapter to guide regulatory capabilities and coach a team of SMEs. You will advance portfolio objectives with scientific rigor and regulatory insight.

The role emphasizes global submissions, regulatory strategy, and cross-functional collaboration across sites, including multiple U.S. and international locations. A discretionary bonus may apply.