Required Education :

Degree in relevant life science discipline

Required Experience :

5-8 years relevant experience

Required technical skills :

  • Regulatory in country affiliate activity
  • Local stakeholder interface
  • Operational liaison with 3rd Parties
  • 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)
  • Reg review local promotional materials via PromoMats
  • Local Regulatory SOP review and update
  • Regulatory activities for launch
  • Coordinate of Response to Questions
  • Preparation/update Product Information
  • Fee calculation
  • 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
  • Informing reliant markets of changes to reference product
    • PQR local submissions (when applicable)
    • Responding to requests from Med info (when applicable)
    • Provision of regulatory data for PV reporting
    • Providing support during external and unannounced audits.
    • Responding to internal requests for technical and/or regulatory information.
    • Assisting with license applications as required.
    • Preparation and submission of Technical/Site Transfer Applications
    • Assisting with the preparation of Marketing Authorisation Applications
    • Ensuring compliance with all regulatory processes, in readiness for both internal and external audits.
    • Ensuring compliance with the regulations of the assigned Countries within Australia Region
    • Use a variety of software packages to produce correspondence and documents, maintain spreadsheets and databases, and locate information and data eg Microsoft Office Suite, Veeva Vault (or comparable EDMS), LorenZ, Trackwise, PromoMat etc
    • A proven ability to consistently deliver to tight timelines, without negatively impacting on quality or departmental budget
    • General regulatory administration duties and compliance requirements
    • Management of artwork generation/ labelling/creation/update of product information (at least 3-5 years)

Additional experience and/or skills :

  • Experience of Medical Devices would be beneficial
  • Experience of other EU region would be beneficial
  • Previous experience of people management/coordination would be an advantage
  • Experience of PV would be beneficial
  • Experience of promotional/non-promotional activities would be an advantage (at least 3-5 years)
  • Good IT skills/knowledge
  • Good organizational skills
  • Good communication skills
  • Pro-active attitude and able to work on own initiative as well as part of a team
  • Ability to prioritize different workloads/multi-task
  • Personal responsibility for ensuring a high standard of work
  • Hands-on experience of product launches within [insert area]

258 Regulatory Affairs Specialist