Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.

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. Crafting 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 acquiring 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 Opportunity:

Supports the Regulatory Affairs team in the preparation of various regulatory submissions to Health Canada (ie, Clinical Trial Applications and Amendments, Investigational Testing Authorizations, New Drug Submissions, Medical Device Applications, Supplemental New Drug Submissions, Notifiable Changes, and Level III Changes), and responses to Health Canada queries.

Responsible for actively participating in cross-functional meetings for regulatory submissions, working closely with relevant local and global stakeholders (Product Development Regulatory, Pharma Technical Regulatory, Product Development Operations, GxP, etc.)

Accountable for keeping up-to-date with evolving Canadian Regulations to facilitate decision-making and ensure regulatory compliance

Contributes to the development and maintenance of Canadian Standard Operating Procedures (SOPs), process maps, and operating guides that are aligned to our Canadian regulatory requirements (Food and Drug Act and Regulations; Medical Device Regulations)

Maintains current knowledge on the relevant electronic document management systems used for regulatory projects to be able to efficiently complete day- to-day activities (eg. Regulatory Information Management System, Global Product Regulatory System, etc), and support cross-functional processes

Active contributor to departmental regulatory information-sharing framework (gDrives, gSites, OneArchive, etc.) and participates in departmental objectives pertaining to process optimization.

Who you are:

You hold a Bachelor’s Degree in Science

You are currently enrolled in a post-graduate program in a relevant field (programs such as Humber College’s Regulatory Affairs program; Seneca College’s Pharmaceutical Regulatory Affairs & Quality Operations program).

Preferred:

You demonstrate strong interpersonal and communication skills, strong problem-solving skills, and strong project management and planning skills

General understanding of Health Canada regulations and guidelines

Microsoft Office and Google Suite skills are required

Basic understanding of automation and artificial intelligence (AI) concepts and applications (ie, OpenAI, Microsoft CoPilot).

Additional Information:

Duration (12 months), work term (Full time, 35 hours per week) and will begin in May 2025

Location: Based in Mississauga, Ontario.

Our team follows a hybrid work structure (minimum 3 days in the office).

This position is not eligible for relocation support. 

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche Pharma Canada has its office in Mississauga, Ontario and employs over 850 employees. The Mississauga facility is bright, vibrant, fosters collaboration and teamwork, and is reflective of Roche's truly innovative culture.

Roche is an Equal Opportunity Employer.