Regulatory Affairs Specialist for Global Labelling

Há 4 dias


Lisboa, Lisboa, Portugal PharmaLex Tempo inteiro
Your Job

As a Regulatory Affairs Specialist for Global Labelling, you will be responsible for the preparation and revision of informative texts for healthcare professionals and patients in EU and non-EU markets. This includes the development of target product/labelling profiles and the management of CCDS/CCSI/RSI creation and maintenance. You will also be responsible for ensuring communication to internal and external stakeholders regarding new and updated CCDSs and escalating deviation and compliance issues to labelling governance bodies as necessary. With experience in labelling documentation and informative texts for innovator drugs on a global level, you will ensure that regulatory affairs, development consulting, and scientific affairs programs and projects are delivered to high standards.

Your Profile

We are looking for a highly skilled individual with a degree in pharmacy, medicine, or other life sciences and professional experience in regulatory affairs with a focus on labelling activities for innovator drugs on a global level. You should have sound knowledge of current pharmaceutical and regulatory requirements in the EU and a proficient understanding of databases, labeling software tools, and project management software. You will be a team player with excellent communication and organisational skills and a passion for delivering high-quality results.

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