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Regulatory Affairs Officer
2 weeks ago
**Specific activities and responsibilities**:
Australia / South Africa / Brazil and GCC experience
**Required education**:
Degree in relevant life science discipline
**Required experience**:
2-4 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.
- 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.
- 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
- Experience of promotional/non-promotional activities would be an advantage
- Experience of CMC-RA and/or Reg-Ops 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 prioritise different workloads/multi-task
- Personal responsibility for ensuring a high standard of work
- 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
- Updating Veeva Vault submission data as required
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