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Senior Specialist, Regulatory Affairs
3 days ago
Your Job
Support EU Hub Manager for medicinal products submissions (new marketing authorization application, renewal, variations, MAH transfer)
· Coordinate with EU local RA team and support Hub Manager for any regional and local EU requests
· Coordination with project teams with internal and external staff and global partners incl. reporting and oversight activities and responsibilities
· Responsible for the planning, filing and prosecution of Regulatory Affairs projects
· Prepare and compilation of the informative texts for healthcare professionals and patients (CCDS, SmPC, PIL, Labeling)
· Update tracking of updates and respective handling of databases and document management systems
Relevant experience and Qualification :
Graduate/Master’s degree in Pharma (B. Pharm/M.Pharm), Science/Biotechnology (B.Sc/M.Sc),
Regulatory Affairs experience in a pharma company, preferably including experience in cosmetics, food supplements and/or herbal products
Experience in EU submission process
Professional Skills and Capabilities
Knowledge of EU regulatory affairs disciplines
Knowledge of labelling regulations and guidance
Excellent verbal and written communication skills
Attention to detail and accuracy
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