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17.10.2019

Drug Regulatory Affairs Assistant (Animal Health)

UPharma Consulting
Консалтинг / Аудит
  • Регион:Киев
Английский (выше среднего)

On behalf of our client, one of the world's 20 leading pharmaceutical companies, we are looking for a successful candidate to fill the position of the DRA Assistant (fixed contract for 1 year) in Kyiv.

 

 

Position overview

 

Support in preparation/ revision/ adaptation of administrative registration/ renewal/ variation documentation for the Marketing Authorization maintenance of veterinarian products, and assistance in tracking of activities within the integration process and processes in accordance with the regional and global strategy, adjusted to local needs and compliance regulations.

 

 

Key responsibilities:

 

  • Ensure maintenance of assigned products and procedures in line with local requirements and regional/global standards;
  • Preparation, review, adjustment of SPC/leaflet/ Artworks texts from Company's respective new and in-line products registered in the countries, or coordination of these activities. Preparation and/or coordination of packaging materials, AW preparation locally and coordination within sub-region if necessary;
  • Based on regional data preparing Application Forms and other documentation for filing and registration of new products and maintenance of existing products;
  • Tracking the product maintenance in appropriate database upon request;
  • Ensure adherence to BI and international compliance rules as well as to local legislations in allocated areas of Regulatory Affairs;
  • Ensuring that all documentation, samples, commercial packs, and other items are provided to relevant Authorities according to the requirements.

 

 

Required qualification & background:

 

  • University degree (veterinarian education is a must);
  • 1 year of working experience at the same or equal position is a plus.

 

Required knowledge & skills:

 

  • Knowledge of regulatory legislation in the veterinary area.
  • Advanced English is a must.