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**Technical Skills Required**:

- Lifecycle maintenance experience
- Providing support during external and unannounced audits.
- Responding to internal requests for technical and/or regulatory information.
- 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