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 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.
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 electronic document management systems used for regulatory projects to be able to efficiently execute day-to-day activities (eg. Regulatory Information Management System etc) and supports cross-functional processes
Maintains departmental regulatory information-sharing framework (gDrives gSites OneArchive etc.)
Participates in departmental objectives pertaining to process optimization
You hold a Bachelors Degree in Science
You are currently enrolled in a post-graduate program in a relevant field (ie Humber Colleges Regulatory Affairs program; Seneca Colleges 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 Notebook LM Gemini).
Additional Information:
Duration: (12 months) work term (Full time 35 hours per week) and will begin in May 2026.
Location: Based in Mississauga Ontario.
Our team follows a hybrid work structure (majority of time in the office).
Relocation benefits are not available for this posting.
#RocheInternshipCA2026
The expected salary range for this position based on the primary location of Mississauga isandof hiring range. Actual pay will be determined based on experience qualifications and other job-related factors as determined by the company.We use artificial intelligence to screen assess or select applicants for this role.
This posting is for an existing vacancy at Hoffmann-La Roche Ltd.
A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Required Experience:
Intern
F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel.