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.
• 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 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

Regulatory Affairs Officer 298