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.