Amgen Associate Regulatory Affairs in Bratislava, Slovakia

Overall Responsibility

  • Supports Regulatory Affairs processes and deliverables in the local office

  • The associate will be working under the supervision of a senior manager and a senior associate

Key activities:

Regulatory Activities

  • Lifecycle management of all products within Amgen portfolio

  • Reviews source text translations

  • Reviews and approves labelling artworks

  • Reviews promotional and non-promotional materials

  • Disseminates relevant information to team(s) as appropriate

  • Participates in local regulatory process improvements initiatives

  • Provides administrative support for Regulatory department

  • Electronic archiving of documentation

Collaboration

  • Works closely with cross-functional colleagues in the affiliate to deliver affiliate goals

  • Exchanges regulatory information & intelligence with other regulatory colleagues and cross-functional

teams

Health Authority Interactions

  • Under general supervision, interacts with local health and regulatory authorities