Regulatory Affairs Officer

Reference: HAR-15-054

Client

Our client is a global top 10 pharma company located at the east side of Antwerp.

This function is office based.

Main purpose

The RA Officer Prepares and manages regulatory submissions (new MAA, variations, renewals).

Tasks

  • Prepares product-information (SmPC/PIL/Labelling) and implements Company Core Data Sheets
  • Initiation and review of artwork
  • Follows-up and updates regulatory information in client databases
  • Liases with local/regional/global key stakeholder (Regulatory Affairs, Business Units, CMC, QA etc.)
  • Archives regulatory documentation

Requirements

  • Bachelor or Master Degree OR equivalent through experience
  • Experiences with regulatory agencies (BE, NL, DE, AU) is not so important but knowledge required of: EU MAAs (DCP, MRP), EU and local (BeNeLux/DE) regulatory maintenance: Variations, Renewals, PSUR submission, EU and local (BeNeLux/DE) labelling/artwork requirements
  • Exceptional organizational skills, works towards and meets deadlines
  • Good presentational and motivational skills; problem solving and decisions making skills; and people management skills
  • Ability to work unsupervised taking responsibility for own actions
  • Excellent verbal and written communication skills in Dutch, German and English

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