Regulatory Clinical Trials Associate

at  Roche

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The Position
Job Title: Regulatory Clinical Trials Associate
Location: Canada Pharma Campus - Mississauga - Hybrid
Duration: 18 months
A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.
That’s what makes us Roche.
The Regulatory Affairs Chapter is committed to ensuring patients have access to improved outcomes more quickly. Our strategic focus is on building, submitting, and obtaining approvals for clinical trial applications, new drug submissions, and new indications. Additionally, we collaborate with external partners to shape regulatory policies that eliminate barriers, enabling faster access to medications and therapies for patients.
The Regulatory Clinical Trial Associate Team is an integral part of the Regulatory Affairs chapter working in a fast paced environment, enabling Canadian patients to participate in Roche clinical trials within our broad portfolio. The team is responsible for filing Clinical Trial Applications (CTAs) and related submissions to Health Canada in adherence to local regulations and guidance. We also lead special projects aimed at enhancing processes, driving change management, and actively participate in regulatory consultations and modernization initiatives.
We are currently seeking a collaborative and motivated individual to join our team as a Regulatory Clinical Trials Associate. In this role, you will be responsible for Clinical Trial Submissions, including the planning, strategy, and timely preparation and approval of Clinical Trial Applications (CTAs) and Medical Device Investigational Testing Authorizations (ITAs) to Health Canada. Your responsibilities will also involve actively participating in cross-functional meetings for study submissions, collaborating closely with local and global stakeholders, contributing to the development and maintenance of local Standard Operating Procedures (SOPs), process maps, and operating guides aligned with Canadian regulatory requirements. Additionally, you will stay updated on relevant regulatory systems used for CTAs/ITAs and support cross-functional processes.

Please refer the Job description for details