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:

  • Degree in life sciences related field

Required experience :

  • 4+ years RA experience

Required technical skills:

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

Additional experience and/or skills:

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

356,357 Regulatory Affairs Specialist (Submission)

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