Overview
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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.
Compensaciones / Incentivos
discretionary annual bonus
benefits package
salary range Indiana USD 106,100–197,000
opportunity to work across multiple regions
inclusive culture
career development opportunities
Responsabilidades
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
Requisitos principales
3–5 years experience with PhD or 5–7 years with Masters in regulatory affairs for IVDs/Medical xqbhyrx 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

📌 Regulatory Affairs Manager, Companion Diagnostics (Barcelona)
🏢 Roche
📍 Barcelona