Regulatory Affairs Specialist

2 weeks ago

Bucharest, Bucureşti, Romania BIOFARM Full time €30,000 - €40,000 per year

Noi suntem BIOFARM, cel mai mare producator de capsule moi din Romania si unul dintre cei mai mari producatori de medicamente din piata de Consumer HealthCare din Romania.

Suntem o echipa diversa, dinamica, unita si puternica. Ne recunosti dupa brandurile deja renumite precum Colebil, Triferment, Bixtonim, Cavit sau Biofen.

Profil candidat

Ne-am bucura sa ne cunoastem daca te regasesti in descrierea de mai jos:

  • Experienta in domeniul intocmirii si inregistrarii dosarelor de medicamente intr-o companie producatoare de medicamente de minim 1 an
  • Absolvent ︀studii superioare chimie/biologie/farmacie
  • Cunoasterea cerintelor legale si a reglementarilor aplicabile in activitatea de inregistrare a produselor medicamentoase, produselor cosmetice si suplimentelor alimentare
  • Cunoasterea metodologiei de intocmire a dosarelor farmaceutice si a dosarelor pentru inregistrarea suplimentelor alimentare
  • Cunoasterea Regulilor de Buna Practica de Fabricatie a medicamentelor
  • Cunostinte de limba engleza - nivel avansat
  • Cunostinte operare PC - nivel avansat

Descrierea job-ului

Mai jos poti vedea activitatile alocate job-ului:

  • Pregateste, verifica, coreleaza si depune la termen documentatia pentru produsele alocate conform planificarilor;
  • Verifica, semneaza de conformitate cu reglementarile in vigoare, textul inscriptionat pe machetele de ambalaje si pe prospect pentru produsele alocate;
  • Urmareste statutul inregistrarii produselor alocate si verifica respectarea termenelor legale pentru depunerea dosarelor de reinnoire si a tuturor actualizarilor necesare;
  • Verifica periodic documentatia din dosarele de inregistrare ale produselor alocate si conformitatea acesteia cu reglementarile in vigoare;
  • Intocmeste si actualizeaza periodic situatia raspunsurilor postautorizare pentru medicamentele autorizate;
  • Actualizeaza si difuzeaza lista materiilor prime si materialelor de ambalare pentru medicamente autorizate;
  • Studiaza legislatia si reglementarile nationale privind inregistrarea medicamentelor, suplimentelor alimentare, cosmetice si dezinfectantilor;
  • Este responsabil de urmarirea tuturor stirilor, reglementarilor si cerintelor Agentiei Nationale a Medicamentului si transmite informarile necesare catre toate departamentele implicate;
  • Mentine istoricul inregistrarii produselor alocate.

La ce sa te astepti de la noi?

  • Oportunitatea de a creste si invata intr-o companie care pune pe primul loc oamenii
  • Pachet salarial motivant și beneficii analizate si imbunatatite anual in functie de evolutia performantelor companiei
  • Oportunitati de invatare si dezvoltare in cadrul companiei
  • Ne place sa sarbatorim succesul, de aceea avem programe de recunoastere a succesului in echipa

HAI in echipa noastra sa contribui si Tu la BINELE DE A TRAI MAI BINE #BIOFARM

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