Regulatory Affairs Intern
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Job Location:
Mississauga - Canada
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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 (ieClinical 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.
Who you are:
You hold a Bachelors Degree in Science.
You are currently enrolled in a post-graduate certificate program in a relevant field (ie Humber Colleges Regulatory Affairs program; Seneca Colleges Pharmaceutical Regulatory Affairs and Quality Operations program).
Microsoft Office and Google Suite skills are required.
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.
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 January 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 job posting.
Who we are
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
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
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.
