Regulatory Affairs Officer (System)

For one of our clients, located in the region of Zaventem, we are looking for a Regulatory Affairs Officer (System):
  • Do you have at least 1 year of experience in the field of Regulatory Affairs? 
  • Do you have a master’s degree in a scientific field?
  • Do you have a good knowledge of languages (NL, ENG/FR)? 
Then 2018 is the year to lift your career to the next step!! 
 
Job Description 
As a Regulatory Affairs Officer you are the key expert in the scientific follow-up for the regulatory dossiers. You are responsible for the product registrations and regulatory system management. Next, you provide for several projects the scientific information of the different products within their therapeutic area. 
 
Registration activities (80%): 
  • You register the medicines following different European and national procedures
  • You write the registration files and keep them up to date and coordinate towards other departments such as Market Access, QA, Logistics, Marketing and Sales.
  • You respond to questions of the government on all the parts of the files
  • You pass information from the registration dossiers to internal and external clients so that the medicines and the information on the market are conform with the approved registration dossiers
Regulatory systems (20 %)
  • You build, manage and follow up on the RA Systems and databases. 
  • You build and review the internal procedures in line with global SOP’s.
Responsibilities 
  • You build up and maintain cooperation with the other sites of our company in Europe.
  • You write and follow up on registration dossier with regard to the general product portfolio by:
    • Collecting and interpreting the information from the company and government sources
    • Preparing, executing and settling of national mutual (MRP) and decentralized (DCP) admission procedures
    • Maintaining of existing registrations (MRP, DCP, and National) by executing variations and 5-year renewals.
  • The RAO will execute following tasks:
    • Organize and control the translations of leaflets and labeling.
    • Write and approve texts for packaging material and marketing
    • Pass through the changes on these texts as a result of variations of 5-year renewals
    • Control artworks
  • RA Systems task will include (but not limited to)
    • Formatting, managing and follow up of trackers, KPI’s (in Excel)
    • Execute of GAP assessments, even inspections
    • Implementation of GOP’s; creation/update of procedures
Profile 
  • You have a Scientific degree in the Life Sciences
  • You have strong communication and organizational skills
  • You have strong analytical mindset
  • You are a team player and you have strong interpersonal skills
  • You pay excellent attention to detail and accuracy
  • You have advanced computer skills (mainly Excel)
  • You possess a good knowledge of languages: fluent in Dutch English and/or French.
Contact Information 

Anneleen De Vos
015 21 11 04
anneleen.devos@valesta.com

Important 

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