Required Technical Skills :

  • Lifecycle maintenance experience
  • 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 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, European and International 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 the European and International Regions
  • 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 :

  • EU (NP, CP, DCP, MRP, Worksharing) experience
  • Local IT, BE or CH experience
  • Previous experience of people management/coordination would be an advantage
  • 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 European and International regions

Regulatory Affairs Specialist - 319

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