Regulatory Affairs Associate

1 semana atrás

Amadora, Lisboa, Portugal ABBVIE Tempo inteiro

Ensure maintenance of Marketing Authorisations of medicinal products, through variations and other regulatory submissions, including label, artwork and local prescribing information.


  • Prepares and initiate redlines to artwork / commodities and attach supporting documents, or changes to package labeling in Artwork Management System.
  • Review Promotional and Nonpromotional materials, ensuring compliance with local regulations, internal policies and procedures, and codes of practice. Notify promotional materials to the Authorities, as required.
  • Maintain awareness of current and new legislation/guidance and ensure that work is in compliance with all relevant statutory requirements and all relevant internal procedures.
  • Write and update local procedures in compliance with the local regulation and internal policies and procedures, if applicable, and implement its training in the affiliate.
  • 3 year working experience with a minimum of 2 years experience required in Regulatory,
  • Having experience interfacing with government regulatory agencies
  • Fluent English both oral and written
  • Working Computer Operation skill
  • Is willing to travel
  • Experience working in a complex and matrixed environment is required
  • Up to date knowledge of legislation
  • Self motivated

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