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.

In this role you are contributing to the preparation and filing of the CMC (chemistry
manufacturing & controls) component of regulatory submissions to meet global filing data and timeline requirements, the sustainment of regulatory compliance at manufacturing sites, and the representation of PTR within internal functions and external groups. The focus of this role is on providing support to global regulatory teams focused on CMC-development leading to successful global commercial registration and/or effective management of post-approvals changes and product lifecycle activities including dossier preparation.
 

The Opportunity:

Responsible for generation and submissions of high quality CMC regulatory documents to global health authorities in accordance with current Good Manufacturing Practices (cGMP), Roche corporate standards and the requirements of applicable health authorities and other regulatory agencies.

Help ensure cross-functional coordination and escalation, as needed.

Ensuring cross-functional PTR deliverables, including assignments delegated by the Technical Regulatory Leader (TRL) are completed compliantly, accurately, thoroughly and in a high quality and timely manner.

Keeping the TRL/Squad fully apprised of project status and potential submission risks and impact to defined regulatory strategies and timelines.

Contributing to regulatory excellence and driving efficiency by identifying opportunities, mitigating risks and supporting continuous improvement.

Supporting product related maintenance and Quality System activities as assigned (e.g., health authority commitments, health authority inspections, discrepancy assessments.

Who you are:

You hold a Bachelor’s Degree in life science disciplines is preferred; 

You are currently enrolled in a Masters Degree program in Biotechnology, Biomedical Discovery and Commercialization or closely related programs. 

Strong knowledge of the pharmaceutical or biotechnology industry and drug manufacturing processes.

Excellent written and verbal communication abilities.

Effective problem-solving and decision-making skills, with a systematic approach to information gathering and analysis.

Demonstrated project management skills, consistently achieving multiple tasks and goals on time, along with learning agility, teamwork, collaboration, and critical thinking capabilities.

Additional Information:

Duration: 12 months, with an approximate start date in January 2026.
Modality: Full Time (35 hours per week) Hybrid (majority of days on - site is required)
Location: Mississauga Campus.

This position is not eligible for relocation support. 

#MBiotech&MBDC

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.