CMC Regulatory Affairs Intern

F. Hoffmann-La Roche AG; Mississauga; On-site; CAD 57,000 - 75,000; Full time

Job summary

Hoffmann-La Roche Ltd. in Mississauga, ON seeks a CMC Regulatory Affairs Intern to support global regulatory submissions and regulatory lifecycle activities. The role emphasizes compliance with cGMP and collaboration across functions to ensure timely patient access to medicines.

You are pursuing a Master’s in Biotechnology or related field, with strong communication and analytical skills. This 12-month full-time internship offers hybrid work with in-office days in Mississauga starting January

Qualifications

• Pursuing a Master's program in Biotechnology, Biomedical Discovery and Commercialization or a related field.
• Strong written and verbal communication skills; ability to present technical information clearly.
• Proactive problem solver with structured, analytical approach to data gathering and decisions.

Responsibilities

• Generate and submit high-quality regulatory documents (CMC) to global health authorities.
• Coordinate cross-functional deliverables to ensure timely regulatory assignments.
• Monitor milestones and communicate risks and strategic impacts to team leads.
• Identify operational efficiencies and contribute to continuous improvement in regulatory processes.
• Support quality system maintenance, health authority commitments and inspection readiness.

Skills

Regulatory affairs

CMC documentation

Cross-functional collaboration

Communication skills

Analytical thinking

Education

Master's degree 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. We believe it's urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.