Key skills
pipCommunication
About this role
Role Overview
- Advising on regulatory development strategies and approval pathways
- Coordinating regulatory activities in EU and US development programmes
- Supporting procedures such as Scientific Advice, PIP and orphan designation
- Contributing to or leading marketing authorisation applications (MAA/NDA)
- Preparing and coordinating regulatory documentation, submissions & publishing, including eCTD and IRIS
- Managing variations and other post-approval regulatory activities
Requirements
- A degree in pharmacy or another relevant life science discipline
- Several years of experience in regulatory affairs for pharmaceuticals
- Experience from industry, a regulatory authority or consulting
- Experience with regulatory submissions or regulatory project coordination
- Excellent communication skills in English and Swedish
Benefits
- Flexibility to work from home or the office,
- Professional development opportunities