Regulatory Data & Content Professional - Commercial Labeling
Roche
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
A 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 Opportunity
As 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 are
- You 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).
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