CMC Regulatory Affairs Intern

Roche; Mississauga; Hybrid; CAD 57,000 - 75,000; Full time

Job summary

Roche is hiring a CMC Regulatory Affairs Intern in Mississauga for a 12-month, full-time program starting January 2027. The role blends office and onsite days (hybrid) with exposure to global regulatory submissions and post-approval strategies.

You will work with cross-functional teams to ensure timely patient access to medicines while gaining hands-on experience in global commercial registration. The internship emphasizes learning in a dynamic, inclusive environment, with opportunities to

Qualifications

• Pursuing a Master’s program in Biotechnology, Biomedical Discovery and Commercialization or related field.
• Solid foundational understanding of biotechnology/pharmaceutical industry and drug manufacturing processes.
• Strong written and verbal communication skills for presenting technical information.

Responsibilities

• 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 complete regulatory assignments accurately and on schedule.
• Monitor milestones and keep leads informed of progress, risks and impacts.
• Identify opportunities for process improvements across regulatory activities.
• Support quality system maintenance, health authority commitments and inspection readiness.

Skills

Biotech knowledge

Communication skills

Problem solving

Team collaboration

Learning agility

Education

Master’s in biotechnology/related field

Job description

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

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.

The Opportunity

• 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

Who you are

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

Additional Information

• Term & Location: 12-month full-time internship starting January 2027 in Mississauga, ON (Hybrid model: minimum 3 days in office)

Relocation benefits are not provided.

#MBiotech&MBDC

The expected salary range for this position based on the primary location of Mississauga is 57 416,00 and 75 358,50 of 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.

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.