Senior Regulatory Affairs Manager

Company
AL2S3 LTD
Location
Sweden (SE)
Salary
Above average salary
Posted
16 Sep 2019
Closes
16 Oct 2019
Ref
Jlregs
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

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.

Responsibilities:

  • 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

Experience/Qualifications;

  • 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

E: joshua@al2s3.com 

L: https://www.linkedin.com/in/joshua-l-072b7a128/