Specific activities and responsibilities:

Australia / South Africa / Brazil and GCC experience

Degree in relevant life science discipline

5-8 years relevant experience for Australia / South Africa / Brazil and GCC experience

Required technical skills :

  • Lifecycle maintenance experience
  • Providing support during external and unannounced audits.
  • Responding to internal requests for technical and/or regulatory information.
  • Request payment of fees and subsequent approval (administrative co-ordination)
  • Assisting with license applications as required.
  • Preparation and submission of documentation for post-approval applications including, but not limited to, variations Renewals, MAH Transfers/COAs
  • Preparation and submission of Technical/Site Transfer Applications
  • Assisting with the preparation of Marketing Authorisation Applications
  • Monitor and maintain up-to-date knowledge of national and European guidelines/legislation.
  • 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)

    Upload of local Product information to national patient/HCP website

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
  • Coordination and administrative support of variation, Renewal Procedure, RtQs and PSUR inc. requesting/securing centrally provided documentation and EDMS support eg Veeva Vault RIM Experience of PV would be beneficial
  • Coordination and management for CPP requests (as required).
  • Coordination and administrative support relating to cessation of marketing / sunset clause / withdrawal of MAs.
  • Coordination and administrative support for Annual Safety Updates/HA instructed safety updates
  • Experience of promotional/non-promotional activities would be an advantage (at least 3-5 years)
  • Updating Veeva Vault submission data as required
  • 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 launche.

269 Regulatory Affairs Specialist