Pharma Technical Regulatory Submission Intern

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

Job summary

Roche in Mississauga invites a Pharma Technical Regulatory Submission Intern to contribute to regulatory submissions and compliance for a 12‑month period. The role offers exposure to global submission processes, cross‑functional teamwork, and data‑driven content management within a dynamic biotech environment.

The internship starts January 2027 with a hybrid model requiring in‑office presence at least 3 days per week.

Qualifications

• Knowledgeable in pharmaceutical/biotechnology industry operations and drug development processes.
• Highly detail‑oriented with proven abilities in data consistency, proofreading, and language mechanics.
• Tech‑savvy and adaptable, with a strong drive to leverage digital tools for efficient workflows.
• Organized team player and strong communicator who thrives under pressure.

Responsibilities

• Prepare global (CMC) regulatory submissions, including Module 3 CTD dossiers and electronic formatting standards
• Manage regulatory information systems and documentation across diverse health authority submission types
• Create and track project timelines to drive operational excellence and streamline regulatory workflows
• Apply data quality management practices using core business IT systems to support data‑driven content management
• Collaborate with cross-functional technical development teams to provide clear regulatory guidance
• Participate in agile methodologies (such as Scrum) to support continuous improvement initiatives

Skills

Pharma industry knowledge

Attention to detail

Digital tools proficiency

Strong communication

Education

Master's degree in Biotechnology, Biomedical Discovery and Commercialization

Bachelor's degree in life sciences

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 Pharma Technical Regulatory Submission Intern, you will join our global team in Mississauga to support the delivery of high‑quality regulatory submissions to health authorities worldwide. You will work alongside cross-functional experts to manage critical submission processes and maintain global compliance for our life‑saving portfolio. This 12‑month internship offers an exciting opportunity to build core expertise in regulatory operations, project management, and data systems while contributing to meaningful patient outcomes.

The Opportunity

• Prepare global (CMC) regulatory submissions, including Module 3 CTD dossiers and electronic formatting standards
• Manage regulatory information systems and documentation across diverse health authority submission types
• Create and track project timelines to drive operational excellence and streamline regulatory workflows
• Apply data quality management practices using core business IT systems to support data‑driven content management
• Collaborate with cross-functional technical development teams to provide clear regulatory guidance
• Participate in agile methodologies (such as Scrum) to support continuous improvement initiatives

Who you are

• Currently enrolled in a Master's degree in Biotechnology, Biomedical Discovery and Commercialization, or a closely related field, with a completed Bachelor's degree in life sciences
• Knowledgeable in pharmaceutical/biotechnology industry operations and drug development processes
• Highly detail‑oriented with proven abilities in data consistency, proofreading, and language mechanics
• Tech‑savvy and adaptable, with a strong drive to leverage digital tools for efficient workflows
• An organized team player and strong communicator who thrives under pressure and dynamic priorities

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.

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.