Subchapter Lead, Regulatory Affairs - Lab Diagnostics

F. Hoffmann-La Roche AG; Indianapolis (IN); On-site; USD 111,000 - 259,000; Full time

Job summary

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

Qualifications

• 7+ years of Regulatory Affairs experience in the diagnostics industry or related field.
• Experience with global submissions for US FDA (Class 1-3) and EU Notified Bodies (Class A-D).
• Knowledge of cGMP’s and QSR’s, ISO13485 and 27001.
• Strong leadership and people development skills; ability to coach and mentor leaders.

Responsibilities

• Lead 10-15 Regulatory Affairs staff to enable impact for customers.
• Act as SME with US FDA, Notified Bodies and other regulatory authorities.
• Monitor global regulatory environments and assess impact of new regulations.
• Drive process standardization and reuse of assets and technical standards.

Skills

Regulatory leadership

FDA submissions

Regulatory affairs

Stakeholder management

Agile leadership

Education

Bachelor's or advanced degree in science

Job description

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