Beschreibung
Focus:
- Experience with regulatory agencies (BE, NL, DE, AU)
Knowledge of:
- EU MAAs (DCP, MRP)
- EU and local (BeNeLux/DE) regulatory maintenance: Variations, Renewals, PSUR submission
- EU and local (BeNeLux/DE) labelling/artwork requirements
- Prepare and manage submissions (new MAA, variations, renewals)
- Prepare product-information (SmPC/PIL/Labelling) and implement Company Core Data Sheets
- Initiation and review of artwork
- Follow-up and update regulatory information in databases
- Liaise with local/regional/global key stakeholder (Regulatory Affairs, Business Units, CMC, QA etc)
- Archive regulatory documentation
- Bachelor or Master Degree OR equivalent through experience
- Managing workloads - ability to organise multiple complex priorities and projects within area of responsibility
- Knowledge of Microsoft Office applications & database- handling
- Excellent interpersonal skills, great understanding of team-culture. Demonstrate a nature of proactively, enthusiasm, independent drive and energetic outlook to tasks
- Exceptional organisational 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