Regulatory Affairs Manager
- Experience Level
- Experienced (non-manager)
AL Solutions are searching for a Regulatory Affairs (RA) Manager to work for a market-leading Scandinavian CRO, based in Sweden, Malmo, or commuting from Denmark, Copenhagen.
This organisation have recently acquired several other CROs within Norway, Sweden, Denmark, and Finland and are now being recognised as the market leader within the Nordic region. This is an opportunity to join a growing organisation with a structured career path and excellent benefits.
They are a friendly team, where their culture means everything, hence their very small staff turnover.
As a Regulatory Manager you will work in close collaboration with members of different project teams and members of the Regulatory group. The CRO may also outsource you to various Pharma clients within a close proximity to your home, or remotely.
- Complete projects in accordance with the project manager, line manager, and client
- Update product information, create common Nordic labelling texts, approve artwork, update FASS tests, DKMAnet, update Liiv, Farmalogg
- Participate in launch meetings
- Handle aRMM
- Report progress of projects to the line manager and client
- Contribute to the development in your area of expertise
- Complete tasks according to regulations, agreements, and budgets
- Ensure defined objectives and plans are met
- Ensure the client’s positive perception and collaboration with the client
- Regulatory submissions for approvals of new products, line-extensions, managing the preparation, content and format of the dossier
- Driving submittions of variations and renewals
- Liaise with health authorities
- Prepare product information
- Clinical trial applications
- Compliance tasks
- Pharmacovigilance responsibilities
- Preferably a Pharmacist background
- Regulatory affairs experience (extensive) within CRO/Pharma companies
- Fluent in Swedish and English
- Strong knowledge of the Pharma and Biotech industry