This position is open at our office in Malmö, Sweden.
LINK Medical is searching for a Regulatory Manager to join our Regulatory Group. Our company is growing, and the portfolio of cross-functional projects is increasing. As a Regulatory Manager, you will work in close collaboration with members of internal and external project teams, with local and international projects, and within a range of different therapeutic areas. The position might require to be outsourced to clients in the greater Malmö area.
- Natural science degree at college/university level, preferably a MSc in Pharmacy or similar
- 2-5 years of experience within Regulatory Affairs
- Experience in GDP is an advantage
- Knowledge about Pharmaceuticals and Biotech Products
- Fluent in Swedish and English (written and oral)
- Ability to show initiative
- Service minded with good cooperation and good communication skills
- Well organized and structured, able to work both independently and in teams
- Independent, flexible, accurate and solution oriented
- Generally good IT skills and use of standard office tools
- Complete projects/services according to the agreement with project manager, line manager and customer
- Ensuring customers’ positive perception of the collaboration with LINK Medical
- Translations and update of Product Information documents including proof-reading, maintenance of FASS texts and update of LiiV
- Translation of educational material
- Compilation and submission of a regulatory dossier
- Post-marketing regulatory maintenance activities
- Regulatory support, e.g. consultation and advice on national legislation and specific requirements
- Review of regulatory documents
- Submission of Clinical Trial Application
- Review of marketing material according to national pharmacode (LER)
- Perform with quality, punctuality and active communication
- Contribute to the development of your area of expertise within LINK Medical
If you would like to know more or have any questions about the position, please contact Regulatory Affairs Director in Sweden, Marianne Jonsson (+46725235100), Marianne.Jonsson@linkmedical.eu
All applications are treated confidentially. Local applicants will be prioritized.
Last day for application: 2019-09-20
LINK Medical offers:
We offer an exciting and challenging position in a Northern European CRO that has a strong local presence. The company focuses on collaboration, sharing of experience and continuous development of our employees. You will be given challenging tasks requiring a good collaboration with both colleagues and customers.
We are looking forward to your application! All applications are treated confidentially. Please apply to the job by filling out the application below: