Regulatory Affairs Intern

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position 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 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), publishing activities, 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) Keeps up to date on relevant internal elec