Regulatory Affairs Specialist

3 weeks ago


Mississauga, Ontario, Canada F. Hoffmann-La Roche AG Full time

Program Management

At F. Hoffmann-La Roche AG, we are seeking a skilled Regulatory Affairs Specialist to join our team. This role will be responsible for delivering global regulatory strategy and executing clinical projects in our portfolio, ensuring the development and maintenance of Roche product licenses to meet patient needs.

In this position, you will lead global Health Authority interactions, represent regulatory affairs on cross-functional project teams, and ensure the consistent and safe use of our medicines through high-quality labels. Additionally, you will understand how data and information contribute to the quality of our submissions.

We are looking for a dynamic and curious individual to contribute to the development and implementation of regulatory strategies and risk mitigations. You will participate in discussions, interpret evolving pharmaceutical regulations, and support gathering of regulatory intelligence necessary to generate insights that meet the needs of health authorities, patients, and prescribers.

Requirements include a degree in Life Sciences or equivalent, 3 years of experience in the pharmaceutical/biotechnology industry, and strong digital literacy. You will also have working knowledge of regional/global drug development processes, regulations, and guidelines, and an understanding of GVP and GCP principles.

This is a great opportunity to work in a hybrid work structure with a collaborative team. We foster diversity, equity, and inclusion, representing the communities we serve, and believe that inclusion is key to understanding people's varied healthcare needs.



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