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Subchapter Lead, Regulatory Affairs - Lab Diagnostics

Job in Indianapolis, Hamilton County, Indiana, 46262, USA
Listing for: F. Hoffmann-La Roche AG
Full Time position
Listed on 2026-08-27
Job specializations:
  • Healthcare
    Healthcare Management, Healthcare Compliance
Salary/Wage Range or Industry Benchmark: 111200 - 258700 USD Yearly USD 111200.00 258700.00 YEAR
Job Description & How to Apply Below
Location: Indianapolis

Roche is seeking a Lab Coagulation and Clinical Chemistry II Subchapter lead in the Medical Value Assays Regulatory Affairs Leadership Team. You will oversee 10-15 Regulatory Affairs staff, coordinating with US FDA, EU Notified Bodies and other international bodies to advance project objectives and ensure regulatory readiness across the portfolio.

You will monitor regulatory environments, drive standardization, and empower teams through agile leadership while collaborating across Squads and

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