Pharma Technical Regulatory Submission Intern

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

Job summary

Roche is seeking a Pharma Technical Regulatory Submission Intern in Mississauga for a 12-month hybrid internship. You will support high-quality regulatory submissions, manage information systems, and help streamline workflows within a global regulatory team.

This role builds core expertise in regulatory operations, project management, and data systems while contributing to patient outcomes. Ideal candidates are enrolled in a Master’s degree in biotechnology or related field, with a completed

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 and dynamic priorities.

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.

Education

Master’s degree in Biotechnology or related field

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.

#MBiotech&MBDC

Salary: 57 416,00 and 75 358,50 of hiring range (Mississauga).

We use artificial intelligence to screen, assess or select applicants for this role.

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.