Regulatory Affairs Registration Manager
Recruiter in Herent
+32 16 30 95 09
· Responsible to support & consolidate the Regulatory Project Teams (RPT) Planning & Tracking for Project/Products under Responsibility
· Create & Update the company’s Regulatory Information Management System (RIMS) with everyday information provided by RPT for all GRA Submission activities
· Responsible for Manufacturing Change control Process entries (RPC – Request for Process Change) within GRA for Technical Variation creation in RIMS.
· Provide ad hoc refresher training to GRA colleagues where users would benefit from learning more about how to effectively use the company’s tools and systems.
· Responsible for the Pre-Publishing (creation of the structure within the company’s electronic document management system (eDMS) and the sequence within the RIMS
· GRA Responsible for making the link between LOCs (Local Operating Companies) & GIO (Global Industrialization Operations) for sharing Regulatory status & allowing QA Release & Supply Business continuity. Customer Services Agent represent GRA & is a Core Team Member of GIO Product Tree meetings
· Provide advice and support regarding the technical aspects of electronic submission build and delivery: i.e. eCTD configuration / lifecycle management and conversion to other submission formats to maximize reuse.
• Experience in the pharmaceutical industry; this should also include RA experience
• University degree (preferably biological/chemical)
• Basic understanding of biologicals/vaccines
• Team spirit, flexibility and accountability, very well organized, good relationships, able to work in multi-cultural and multi-disciplinary environment
• Can work under stress and to deadlines
• An eye for detail