Regulatory Labelling Associate (fixed-term)

at  Roche

Budapest, Közép-Magyarország, Hungary -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate24 Dec, 2024Not Specified26 Sep, 2024N/AGood communication skillsNoNo
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Description:

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The Position

WHAT WE DO:

Global Labeling (PDRL) ensures the consistent and safe use of our medicines through high-quality labels to create and maintain scientifically-sound, evidence-based, and balanced labels.
The Labeling function leads the development and update of core datasheet (CDS), EU Summary of Product Characteristics (SmPC) and US Product Information (USPI) in partnership with Regulatory Program Management and cross-functional experts throughout the lifecycle. In addition, a Labeling compliance unit tracks CDS implementation into local product Information and ensures end-to-end labeling oversight and adherence to regulatory standards.

Responsibilities:

Please refer the Job description for details


REQUIREMENT SUMMARY

Min:N/AMax:5.0 year(s)

Information Technology/IT

Pharma / Biotech / Healthcare / Medical / R&D

Software Engineering

Graduate

Proficient

1

Budapest, Hungary