Regulatory Affairs Intern
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What you'll do
- 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
What they're looking for
- You hold a Bachelor’s Degree in Science
- You are currently enrolled in a post-graduate program in a relevant field (ie, Humber College’s Regulatory Affairs program; Seneca College’s Pharmaceutical Regulatory Affairs & Quality Operations program)
Nice to have
- 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)
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
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 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 Bachelor’s Degree in Science
You are currently enrolled in a post-graduate program in a relevant field (ie, 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, Notebook LM, Gemini)
Additional Information:
Duration (12 months), work term (Full time, 35 hours per week) and will begin in January 2027
Location: Based in Mississauga, Ontario.
Our team follows a hybrid work structure (minimum 3 days in the office).
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.
Who we are
A healthier future drives us to innovate. Together, more than 100’000 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.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.
Company
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