Overview

¿Es este el puesto que está buscando? Si es así, siga leyendo para obtener más detalles y no olvide enviar su solicitud hoy mismo.In this role you drive regulatory submissions for complex products within Roche’s General 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 / Beneficios

discretionary annual bonusbenefits packagesalary range Indiana USD 106,100–197,000opportunity to work across multiple regionsinclusive culturecareer development opportunities

Responsabilidades

Oversee regulatory document and submission compilation for complex products/programsDevelop and manage parts of global regulatory submissions and registration plansInterface with external management and stakeholders, building lasting relationshipsContribute to audits through preparation, execution,



and follow-upLead adaptation to evolving regulatory requirements and regional nuancesApply regulatory thinking to guide project strategies and accelerate approvalsPartner with internal and external stakeholders to develop optimal solutionsDemonstrate decisive leadership and initiative in addressing opportunities and challengesFoster 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 devices/Pharma/Biopharmaceuticals xhfqzwm Knowledge of European, US, China and other international regulationsExperience with Daily Management and Continuous Improvement practicesAbility to manage complex work and aspects of global projectsStrong external stakeholder management and communication skillsstakeholder managementstrategic thinkingleadership and initiativeRegulatory submissions strategyKnowledge of IVDs/Medical devices/Pharma regulationsRegulatory intelligence and interpretation across regions

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