Global Labeling Specialist

Requirements to candidate 

• Degree in biomedical sciences (Medicine/Pharmacy/Veterinary/Pharmaceutical Sciences/ Science) or Chemistry

• Two or more years of regulatory experience within relevant discipline/procedures (Labelling updates)
• Good knowledge of regulatory requirements, process, procedures & pathways, with preferable focus on Labelling/Safety text updates
• Understanding of scientific and health principles related to healthcare product development and regulations.
• Knowledge of regulatory requirements and procedures for labelling
• Experience in registration of pharmaceutical in the EU and other countries.
• Good computer skills – MS Office applications esp. Word, Excel, Power Point and Document  
• Excellent  written and oral knowledge of English

Main responsibilities: 

• Prepares and maintains high quality Product Information (Summary of Product Characteristics - SmPC, Patient Information Leaflet - PIL, Labelling – LAB (text on packaging)), User testing and other required documents in English for selected portfolio medicinal (and-or nonmedicinal) products portfolio in accordance with ROW countries national requirements and legislation with limited oversight.
• Answers questions related to the given parts of registration documentation and support to project teams, stakeholders and customers, as required.
• Continuously updates work plan based on coming tasks with reasonable regulatory deadlines and priorities, communicates with peers and supervisors to ensure alignment on issues, questions and goals.
• Coordinates and tracks information about new safety labelling evaluation, outcomes and implementation and procedures labelling including change control process, queries from/to competent authorities and related communication and provides updates to stakeholders.
• Active participation in required updates and maintenance of systems, databases and corporate data to trigger and log regulatory reporting including content and interface management, administering and training(s)