Regulatory Affairs Manager, Companion Diagnostics

In this role you drive regulatory submissions for complex products within Roche’s Global Regulatory Affairs, focusing on Companion Diagnostics. You will shape global strategies, manage external relationships, and navigate evolving regulatory environments to accelerate worldwide approvals. You will collaborate across functions and regions, influencing decisions and ensuring patient access to diagnostics and medicines. This is an opportunity to contribute to a mission-driven culture that values inclusion and impact.

• discretionary annual bonus
• benefits package
• salary range Indiana USD 106,100–197,000
• opportunity to work across multiple regions
• inclusive culture
• career development opportunities

• Oversee regulatory document and submission compilation for complex products/programs
• Develop and manage parts of global regulatory submissions and registration plans
• Interface with external management and stakeholders, building lasting relationships
• Contribute to audits through preparation, execution, and follow-up
• Lead adaptation to evolving regulatory requirements and regional nuances
• Apply regulatory thinking to guide project strategies and accelerate approvals
• Partner with internal and external stakeholders to develop optimal solutions
• Demonstrate decisive leadership and initiative in addressing opportunities and challenges
• Foster an inclusive, collaborative environment and resolve conflicts constructively

• 3–5 years experience with PhD or 5–7 years with Masters in regulatory affairs for IVDs/Medical devices/Pharma/Biopharmaceuticals
• Knowledge of European, US, China and other international regulations
• Experience with Daily Management and Continuous Improvement practices
• Ability to manage complex work and aspects of global projects
• Strong external stakeholder management and communication skills

• stakeholder management
• strategic thinking
• leadership and initiative
• Regulatory submissions strategy
• Knowledge of IVDs/Medical devices/Pharma regulations
• Regulatory intelligence and interpretation across regions