Senior Regulatory Affairs Manager

Sweden (SE)
Above average salary
16 Sep 2019
16 Oct 2019
Regulatory Affairs
Full Time
Contract Type
Experience Level

Joshua Leggett is in search for a Regulatory Affairs Manager to work for my client in Sweden, Malmo. They are a market-leading Nordic focused CRO that are at the heart of expansion and beginning to open offices in northern Europe. Now is a great time to be joining them…Especially within the Regulatory Affairs division.

The regulatory affairs team is the biggest function within this CRO. You can therefore be exposed to a large variety of work, receive excellent on-the-job and off-site training, meaning that you can progress rapidly through your career. The team is further growing, with more and more exciting projects and sponsors to work with.

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.


  • Complete projects/services according to the agreement with project manager, line manager and customer
  • Ensuring customers’ positive perception of the collaboration with us
  • 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 the company


  • 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 

If you’re ready for that next step in your career, reach out to me to secure an interview slot;

T: +44 (0) 203 778 0909