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International Open Positions

With 530 years of heritage, more than 3.000 employees, a leading Research and Development Center and two major production sites in Prague and Bucharest, Zentiva strives to be the champion of Generics to support the daily healthcare needs of people living in Europe.The growth of our organization brings new opportunities for our people to fulfil their potential. It also positions us well to attract the best talent and retain our team to secure our success for future generations. Join us!

Drug Master File Specialist

Your responsibilities:

DMF support for all Zentiva sites, external documentation evaluation related to API (ASMF, CEP, and TP), documentation preparation and DMF support within the registration procedures, API documentation maintenance within assigned portfolio according to the valid legislation and information received from external partners, change control management related to any API changes within assigned portfolio

Evaluation of documentation related to active substances or raw materials from external suppliers requested by Procurement or Regulatory Affairs

  • Comments communication with external suppliers / contractors through Procurement or directly
  • Change control management related to any API changes within assigned portfolio in all Zentiva sites
  • Documentation support for registration submission in time within pharma project and registration pipelines
  • Documentation preparation in eDMS including requested documentation (LoA, LoE, declarations...) for registration purposes
  • DMF support within the registration procedures including deficiency letters management
  • Valid documentation maintenance according to the current legislation and notifications from contract partners

We require:

University degree in Natural / Chemical Science / Pharmacy

  • Min. 1 – 2 years of experience in Regulatory Affairs/Pharmaceutical industry
  • Experience with Drug Master File is an advantage
  • An ability to lead projects
  • Excellent communication skills
  • Knowledge of relevant legislation in EU/non-EU countries

We offer:

  • An opportunity to work for a successful international company
  • An opportunity to broaden your organizational skills
  • Continuous language and personal development
  • An attractive compensation & benefits package

Contact

Zentiva
Klára Pavlíková