(Senior) Regulatory Affairs Manager

Company
AL2S3 LTD
Location
Malmö (Kommun), Skåne (SE)
Salary
40k-55k SEK
Posted
28 Aug 2019
Closes
27 Sep 2019
Ref
regsmanmalmo
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

(Senior) Regulatory Affairs Manager

AL Solutions are searching for a Regulatory Affairs Manager or a Senior Manager to work for our 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

Requirements:

  • 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

 

Our client offers an exciting and challenging position in a European CRO that has a strong local presence. The company focus on collaboration, sharing of experience and continuous development. You will be given meaningful tasks requiring a good collaboration between industry, clinical and scientific teams and the authorities. We offer a competitive salary, pension and insurance scheme and a bonus scheme for all employees.