Regulatory Affairs Officer
That's XPE. For one of our clients we are looking for: Regulatory Affairs Officer Organisation description:
Our client is a pharmaceutical leader in generic medicines, they are hiring a trilingual (NL-FR-EN) Regulatory Affairs Officer with a first experience, is a full time permanent contract.
Department: Pharmaceutical Affairs
N+1: Regulatory Affairs Manager
Purpose of the job:
Managing the life-cycle of medicinal products from preparation of the registration dossier to the launch of the registered drug on the market, including the follow-up and finalization of new registrations, the preparation for market access, finalizing the registration in Luxembourg and informing internal departments concerned to ensure a smooth launch.Job description:
Manage existing registrations in Belgium and Luxembourg and update product information:
- Evaluate and analyze the product-specific documentation in response to the Pharmacovigilance Risk Assessment Committee (PRAC) evaluation, safety variations, decisions of the EMA or the famhp and communicate internally to the Quality team and other RA colleagues.
- Prepare, submit and follow-up/coordinate safety variations in collaboration with the Local Pharmacovigilance Officer and the RA Manager.
- Evaluate, analyze and prepare variation dossiers that give rise to changes in module 3 (change controls) in consultation with the RA Manager.
- Compile, submit and follow-up of variation dossiers and renewals to the competent authorities in compliance with the latest regulatory guidelines
- Analyze and respond to remarks/questions of the competent authorities
- Prepare and submit the ‘Notification de modification' in Luxemburg
- Review and approve packaging materials
Ensure proper management of the databases:
- Update database with regard to implementation of Article 57 (2) van EC 726/2004.
- File and archive submitted variations with regard to the corporate Electronic Record Archive (EDA).
- Communicate changes to existing registrations
Acquiring and maintaining knowledge about national and international laws and guidelines:
- The reading of legislation, guidelines and literature related to the job content
- Attend information meetings, workshops and meetings
- Comply, maintain and improve existing procedures and work instructions related to job in accordance with the relevant legislation and guidelines.
- Write, evaluate and apply new work instructions and procedures in accordance with the relevant legislation and guidelines.
Master pharmaceutical or biomedical sciences
A first experience in Regulatory Affairs is a must
- Excellent verbal and written communication skills
- Languages: Dutch, English and French
- Computer skills: Word, Excel, Outlook
- Team player and team spirit
- Detail oriented
- Excellent planning skills
- Permanent contract on the client's payroll
- Work within a dynamic atmosphere and great team-spirit
- Full time by preference, 80 or 90% is negotiable
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002 XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713