About the role#
As a CMC Regulatory Affairs Intern, you will support the preparation and global filing of critical regulatory submissions. You will work with our regulatory affairs team to manage product lifecycles and uphold manufacturing quality standards. This role provides hands-on experience in global commercial registration and post-approval regulatory strategies.
What you'll do#
- Generate and submit high-quality CMC regulatory documents to global health authorities.
- Ensure adherence to cGMP and health authority requirements.
- Coordinate cross-functional deliverables to ensure assignments are completed accurately and on schedule.
- Monitor project milestones and keep team leads informed of progress and submission risks.
- Support quality system maintenance, health authority commitments, and inspection readiness.
- Identify operational efficiencies and contribute to process improvements.
What you'll need#
- Currently pursuing a Master’s program in Biotechnology, Biomedical Discovery and Commercialization, or a related field.
- Foundational understanding of the biotechnology or pharmaceutical industry and drug manufacturing processes.
- Strong written and verbal communication skills with the ability to present technical information clearly.
- Proactive problem-solving skills with a structured, analytical approach to data and decision-making.
- Strong organizational abilities and a collaborative mindset.
Location & details#
- Location: Mississauga, Ontario.
- Term: Winter 2027 (12-month full-time internship).
- Work Modality: Hybrid (minimum 3 days in office).
- Compensation: This is a paid position.
About Roche
Roche is a Swiss-based public company operating within the biotechnology research sector. Established in 1896, the organization maintains a workforce of over 10,000 employees. The firm focuses on the development of pharmaceuticals and diagnostic tools, including specialized solutions for oncology, immunology, infectious diseases, and diabetes management. Its operations integrate medicine and diagnostics to support personalized healthcare approaches.
