Publicat 15 Apr 2019 | Reactualizat 03 Iun 2019 | Expiră 09 Iun 2019

Regulatory Affairs Specialist

1 post |  Aplicare externa
Ai aplicat
Expirat
Nu uita să îți finalizezi aplicarea pe site-ul angajatorului! Vei avea mai multe șanse de a fi chemat la interviu.
Anunț inactiv

Acest anunț a expirat și nu este disponibil pentru aplicare.

Înapoi la joburi

Descrierea jobului

For our client, Bausch Health - one of the oldest continually operating companies in the US today - we are looking for a Regulatory Affairs Specialist.

Main Responsibilities:

  • Establishes and maintains good relationship with all involved regulatory institutions in Romania.
  • Monitoring, following, reporting and implementing of all local and EU legislation/regulations, Company’s SOPs and Partner companies’ Policies & procedures according to business agreements
  • Monitoring national and EU legislation (where applicable) for new information related to the regulation and legislation and inform the appropriate local employees and corporate regulatory functions about the changes
  • Preparation and submission to the Authorities of notification dossiers of medical devices and food supplements
  • Overall responsibility for regulatory activities in cooperation with corporate functions for company’s products. Keeps up-to date on Company products
  • Files preparation & application for: authorization, renewal, variations, transfers, safety alerts, notifications, for all company’s products marketed and/or registered in Romania or new products intended to be marketed in Romania.
  • Follows-up all steps for authorization/approval of the above
  • Managing of mock-ups/artworks for all company’s marketed medicines, medical devices and food supplements
  • Timely information of new submissions, approvals, timelines, deficiency letters, delays, to the relevant staff in Local Affiliate and Corporate Functions and partners’ companies according to business agreements
  • Providing information to Global Regulatory Team about submission, timelines, deficiency letters, delays
  • Keeping the local and global updated database in line with all registrations and amendments performed through Regulatory Department
  • Ensures the application for pricing within the agreed timelines for all new/strategic products that are registered in Romania, and ensure earliest possible price approvals. It is applicable also for annual price corrections.  Support commercial in all their promotional activities (eg: in the development and approval of promotional material, presentations etc.);  Approve all marketing material to be in line with the approved labeling as per the dossier/ companies policies / local laws;  Implementation of Quality Management System and involvement in all relevant quality topics
  • Archiving all Regulatory, Pricing, Medical and Quality relevant documents
Requirements:
  • University degree, preferably Pharmacy, General Medicine, Bioscience
  • Previous experience in the pharmaceutical industry, including Regulatory Affairs - min 2-3 years
  • Familiar with current legislation and regulations, European and local, for pharmaceutical products
  • Good PC knowledge- MS Office, Internet, Email
  • Fluent in both spoken and written English
  • Ability to analyze, to prioritize and to plan the activities
  • Ability to work independently and in cross functional teams
  • Excellent listening and communication abilities
  • Strong interpersonal skills
  • Open and honest

Descrierea companiei

Grupul Adecco este lider mondial în furnizarea de servicii specializate de resurse umane. Serviciile pe care le oferim vin ca o oglindire a cunoașterii pieței din România și a înțelegerii clare a nevoilor clienților, ca rezultat a 50 de ani în care am acumulat experiență și cunoștințe și în care am implementat tehnici și metode moderne de lucru.

Ai aplicat
Expirat
Nu uita să îți finalizezi aplicarea pe site-ul angajatorului! Vei avea mai multe șanse de a fi chemat la interviu.
Regulatory Affairs Specialist  -  Adecco Romania

E timpul pentru un browser mai bun

De la 1 octombrie 2019, te informăm că site-ul eJobs.ro nu va mai putea fi accesat prin browser-ul Internet Explorer din cauza funcționalităților reduse ale acestuia. Accesează-ne cu încredere folosind unul dintre browserele mai moderne: Google Chrome, Mozilla Firefox, Safari sau Edge.

Am înțeles
close