Global Regulatory Lead Pathology Diagnostics (Hybrid)

F. Hoffmann-La Roche AG; Tucson (AZ); Hybrid; USD 106,000 - 197,000; Full time

Benefits offered by this job

Discretionary bonus

Job summary

Roche is seeking a Regulatory Affairs professional to support submission compilation for complex diagnostic products within the Pathology and Digital Pathology portfolio. You will interface with stakeholders across functions and countries to shape regulatory pathways and patient access.

The role emphasizes developing strategies, audits support, and leading parts of global projects while partnering with external customers to navigate evolving regulatory environments. Hybrid, Tucson-area position.

Qualifications

• Bachelor’s or Master in Life Science or related field; advanced degree preferred.
• 3–5 years with PhD, 5–7 with Masters, 6–8 with Bachelor in regulatory affairs or equivalent.

Responsibilities

• Oversee regulatory document and submission compilation for complex products.
• Develop and manage portions of global regulatory submissions and registration plans.
• Apply knowledge of US FDA regulations for IVD instruments, software, accessories and systems.
• Lead audits support and collaborate with external stakeholders to influence strategies.

Skills

Regulatory Affairs

USFDA knowledge

Stakeholder management

Global regulations

Education

Bachelor's/Master Life Science

Advanced degree preferred

Job description

Roche is seeking a Regulatory Affairs professional to support submission compilation for complex diagnostic products within the Pathology and Digital Pathology portfolio. You will interface with stakeholders across functions and countries to shape regulatory pathways and patient access.

The role emphasizes developing strategies, audits support, and leading parts of global projects while partnering with external customers to navigate evolving regulatory environments. Hybrid, Tucson-area position.