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
At Roche, we deliver medical solutions and develop innovations for the future in order to transform patients' lives. We believe that good business means a better world and we commit ourselves to scientific rigour, unassailable ethics, and access to medical innovations for all.


This exciting internship opportunity is located at the Mississauga, Canada site within the Submission Management Group (SMG) of the global Pharma Technical Regulatory (PTR) organization at Roche. PTR provides technical (CMC [chemistry, manufacturing, and controls]) regulatory oversight for global submissions, changes assessments, and discrepancies. PTR plays a critical role in maintaining the regulatory compliance of Roche's global portfolio of products. Within PTR, SMG manages the submission and data process in coordination with technical regulatory strategy teams.

The Opportunity:

The PTR Submission Manager Intern works with regulatory subject matter experts within and across functions to enable the delivery of high-quality CMC regulatory submissions to health authorities worldwide. They apply submission and data management skills to their work to support global CMC regulatory submissions at the document and data level by providing document and information management support for submissions of medium to low complexity.

Work with diverse submission types across global health authorities, focusing on regulatory, GMP-compliant documentation and regulatory information management systems. Gain expertise in CMC regulatory submissions, including preparing Module 3 of the CTD dossier and ensuring compliance with eCTD formatting standards. Develop project management abilities, including creating and managing timelines, and driving a project in operational excellence to streamline processes and improve efficiency. Build proficiency in critical IT business systems, data quality management, and a data-driven approach to regulatory content and information management. Collaborate with cross-functional teams to provide guidance to technical development/product teams, support Pharma Technical units, and improve communication and interpersonal skills. Engage with agile methodologies, including Scrum, while participating in initiatives to enhance ways of working.

Who you are:

Hold a Bachelor's degree in a life science discipline. Currently enrolled in a Master's program in Biotechnology, Biomedical Discovery and Commercialization, or a closely related field Possess strong knowledge of the pharmaceutical or biotechnology industry, drug development processes, and data accuracy through detailed analysis. Demonstrate excellent written and verbal communication, as well as strong editing and proofreading abilities with a solid grasp of language mechanics. Exhibit advanced technological skills with a drive to leverage technology for improved efficiency and workflows. Show high motivation, adaptability, and the ability to work independently or collaboratively while effectively engaging with diverse stakeholders. Demonstrate exceptional organizational and time management skills, the ability to perform under pressure, and flexibility to handle dynamic priorities reliably.

Additional Information:

This position is a 12 month work term (full-time) and will begin January 2026. Position based in Mississauga, ON. Our team follows a hybrid work structure (minimum 3 days in the office). Please apply through our Workday Portal. Candidates who do not submit through Workday will not be considered for the role.

Relocation benefits are not available for this job posting.

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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.