Regulatory Affairs Specialist

regulatory affairs, life sciences, rejestracja, specialist

Key responsibilities:

  • Preparing registration submissions and post-approval variations for medicinal products
  • Managing CMC (Chemistry, Manufacturing and Control) Variations for Finished Products and Active Pharmaceutical Ingredients
  • Maintaining Product Information Files (PIF) for cosmetic products and submit notification to PL HA for Medical Devices
  • Performing regulatory activities for assigned brands / product categories (medicinal products/cosmetics/medical devices)
  • Coordinating artworks updates as part of variations submission or other regulatory updates or new product launch and liaison with other functions to manage implementation
  • Verifying and approving promotional materials for assigned brands
  • Liaising with authorities responsible for the Marketing Authorization of concerned products in Poland
  • Tracking local and the EU legislation related to authorization and maintenance of authorization for different categories of products.
  • Publishing eCTD sequences for new MAA application/variations for medicines
  • Back-up for reporting safety-related information to Global Safety Team (via TrackWise)
  • Preparing draft answers to medical enquiries for assigned brands

Requirements:

  • Minimum 3-years of regulatory experience with medicinal products
  • Higher education in medical, pharmaceutical, chemical, biological or related fields
  • Very good knowledge of Polish and EU regulations regarding medicinal products
  • Excellent organizational and planning activities
  • Good communication skills
  • Fluent in spoken and written English


If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.



Hays Poland sp. z o.o. is an employment agency registered in a registry kept by Marshal of the Mazowieckie Voivodeship under the number 361.


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podsumowanie

Rodzaj pracy
Stała
Branża/Sektor
Farmacja
Lokalizacja
Warszawa
Obszar specjalizacji
Pharma
Nr ref.:
1183618

Skontaktuj się z konsultantem

Skontaktuj się Aleksandra Figielska, Konsultant odpowiedzialny za tę rekrutację, znajduje się Warszawa
Hays, ul. Marszałkowska 126/134

Telefon: 722000702

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