Specific activities and responsibilities:

Regulatory Assessment for Quality and Safety changes (inc labelling updates and non CMC administrative changes)
Creation/update Country Label Deviation
Update and approval local artworks
Provision of local reg intel
Update local site licenses (GMP site renewals)
Local Regulatory SOP review and update
Health Authority Fee maintenance
Coordinate of Response to Questions
Preparation/update Product Information
Preparation /update local abbreviated PI (if applicable)
Preparation of Renewal Procedure eg local document identification and preparation
Preparation for Variations inc. RtQs, requesting/securing centrally provided documentation
Preparation for Annual Safety Updates/HA instructed safety updates
Regulatory support in relation to local requirements relating to cessation of marketing / sunset clause / withdrawal of Mas

Providing support during external and unannounced audits.

Required education:

RA knowledge and background, MS-Excel basic and Presentation skills, coordination/organizational/multi task skills

Organized, methodical, adaptable, sense of priorities, rational, ready to learn and grow.