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Regulatory Affairs Registration Manager

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Aline Vandermeeren
Recruiter in Herent



Aline Vandermeeren
Recruiter in Herent
+32 16 30 95 09


Job description

· 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.

Profile

• 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

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