Regulatory Affairs Associate - Budapest (határozott idő) 2018.01.11.

Referenciaszám: VEN-03768-IL1A

On behalf of our multinational pharmaceutical partner we are looking for a Regulatory Affairs Associate to join their team in Budapest for fixed-term

 

Main tasks:

  • To ensure compliance of the product portfolio to applicable regulations, guidelines and standards with cooperation of contracted parties
  • Monitor the preparation, submission of dossiers for registration and compliance to achieve registrations for the specific product portfolio, within agreed timelines. This includes:
    • To define / collect the requirements for local submission of registration dossiers
    • To ensure regulatory compliance and publishing using electronic databases and repositories
    • To ensure the update and maintenance of the dossiers after registration
    • To ensure the renewal of registration of products by defining the accurate timeline
  • To advise organization of potential regulatory risks in normal day to day activities and recommend compliant actions
  • To liaise with distributors in the region, to achieve and maintain registrations
  • To keep abreast of the dynamic regulatory, compliance and statutory requirements in the global, regional and local environment to ensure organizational compliance

Requirements:

  • Master’s degree in health-related science, life science; Pharmacy or Medical degree
  • Fluent English both in written and oral
  • At least 1-3-year regulatory experience in pharmaceutical environment (Experience in registration of medicines is must)
  • Project management skills and ability to multitask
  • Ability to understand and apply European and local requirements