Technical Skills Required:

  • 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, variations, renewals and 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 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 (or comparable EDMS), LorenZ, Trackwise 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

 

Required Education:

Degree in relevant life science discipline

Required Experience:

2-4 years relevant experience

Additional Experience and/or Skills:

• Experience of promotional/non-promotional activities would be an advantage
• Good IT skills/knowledge
• Good organisational 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

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