RA Consultant

Contact name: Matthew Vesty

Contact email: matthew.vesty@medella.life
Job ref: 253
Published: about 1 month ago
Job Description

This is a 12 months freelance position based in Malmo. The project will require 2-3 days per week commitment. The main focus will be on support with national phase activities (mainly patient information and artwork).

The Work May Include, But Is Not Limited To
  • Operational and/or strategic regulatory project management.
  • Communication with local Health Authorities including preparation and submission of regulatory applications.
  • Update and translation of local product information.
  • Update of labelling and review of artworks.
  • Management of local regulatory databases.
  • Management of local catalogue texts.
  • Local regulatory advice.
  • MSc in Pharmacy, or equivalent.
  • At least 3 years of experience in Regulatory Affairs
  • Excellent understanding of registration procedures and requirements as well as product life cycle management from regulatory affairs perspective.
  • Excellent communication skills (oral and written) in both Swedish and English language
  • Having an open eye for the needs of your customers and the ability to adjust to these needs.
  • Able to work to deadlines and solving issues in a pragmatic and proactive way.
  • Ensuring you are able and willing to dig into the details yet keeping an eye on the overall goal of the project.
  • At least 4 years of experience in Regulatory Affairs from the pharmaceutical industry, preferably at both subsidiary and headquarter level.