The PositionA healthier future. It's what drives us to innovate. To continuously advance science and ensure access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.
The OpportunityAs a Data & Content (GG5) entry-level individual contributor, you will join our dynamic regulatory team to support the timely development, maintenance, and revision of labeling artwork for assigned products and projects.
You are supporting the labeling lifecycle by coordinating closely with senior staff members on cross-functional deliverables, communications, and daily standard workflows.
You are managing the end-to-end process for product labeling under the direct guidance of your manager, driving efforts to build greater efficiency into our internal procedures.
You are contributing to critical regulatory milestones by supporting official correspondence with the FDA, interpreting agency comments, and executing necessary resubmissions.
You are maintaining operational excellence by participating in the development and implementation of updated PDR/CML Standard and Department Operating Procedures (SOPs/DOPs).
You are safeguarding quality standards by proactively identifying compliance issues and supporting dedicated efforts to address and close any operational gaps.
Who you areYou hold a Bachelor’s Degree, with a strong preference for life sciences disciplines.
You bring 3-5 years of dedicated work experience in regulatory drug, biologic, and device labeling.
You demonstrate a strong foundational understanding of regulations, development processes, and GxP quality guidelines (including FDA and other relevant industry standards).
You possess robust computer literacy, with advanced proficiency in Microsoft Office Suite (Word, PowerPoint, Excel), Adobe Acrobat, and industry-standard publishing or document management software.
You excel in teamwork and collaboration, showing the technical expertise needed to build strong internal relationships, resolve conflict openly, and hold yourself accountable to team commitments.
Relocation benefits are not available for this posting.
The expected salary range for this position based on the primary location of Mississauga is 89,256.00 and 117,148.50 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.
