CMC Regulatory Affairs Intern

Roche • Mississauga, ON

17h • CA$57,416 - CA$75,359 • Hybrid

About The Position

As a CMC Regulatory Affairs Intern, you will support the preparation and global filing of critical regulatory submissions to ensure compliance and timely patient access to medicines. Joining our dynamic regulatory affairs team, you will collaborate across functions to manage product lifecycles and uphold global manufacturing quality standards in an inclusive, innovative environment. This role offers a unique opportunity to gain hands-on experience in global commercial registration and post-approval regulatory strategies.

Requirements

• Currently pursuing a Master’s program in Biotechnology, Biomedical Discovery and Commercialization, or a related field.
• Solid foundational understanding of the biotechnology/pharmaceutical industry and drug manufacturing processes.
• Strong written and verbal communication skills with an ability to present clear technical information.
• Proactive problem solver with a structured, analytical approach to gathering data and making decisions.
• Strong organizational abilities, learning agility, and a collaborative mindset to thrive in a team environment.

Responsibilities

• Generate and submit high-quality (CMC) regulatory documents to global health authorities.
• Ensure strict adherence to current Good Manufacturing Practices (cGMP) and applicable health authority requirements.
• Coordinate cross-functional deliverables to ensure regulatory assignments are completed accurately, compliantly, and on schedule.
• Monitor project milestones, keeping team leads informed of progress, submission risks, and strategic impacts.
• Identify operational efficiencies and contribute to continuous improvement initiatives across regulatory processes.
• Support quality system maintenance, health authority commitments, and inspection readiness activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Intern