Regulatory Affairs Officer
Our client is a global top 10 pharma company located at the east side of Antwerp.
This function is office based.
The RA Officer Prepares and manages regulatory submissions (new MAA, variations, renewals).
- 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
- 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