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ACINO Україна — вакансия в Global Labeling Specialist
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Global Labeling Specialist

ACINO Україна
7 месяцев назад
09 июля 2023
Киевул. Радищева 10/14

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)
ACINO Україна — вакансия в Global Labeling Specialist: фото 2

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