Required Education:
Degree in relevant life science discipline
Required Experience:
5-8 years relevant experience
Required Technical Skills:
Regulatory in country affiliate activity
Local stakeholder interface
Operational liaison with 3rd Parties
Regulatory Assessment for Quality and Safety changes (inc labelling updates and non CMC administrative changes)
Creation/update Country Label Deviation
Update and approval local artworks
Provision of local reg intel
Update local site licenses (GMP site renewals)
Reg review local promotional materials via PromoMats
Local Regulatory SOP review and update
Regulatory activities for launch
Coordinate of Response to Questions
Preparation/update Product Information
Fee calculation
Preparation/update local abbreviated PI (if applicable)
Preparation of Renewal Procedure eg local document identification and preparation
Preparation for Variations inc. RtQs, requesting/securing centrally provided documentation
Preparation for Annual Safety Updates/HA instructed safety updates
Regulatory support in relation to local requirements relating to cessation of marketing / sunset clause / withdrawal of MAs
Informing reliant markets of changes to reference product
PQR local submissions (when applicable)
Responding to requests from Med info (when applicable)
Provision of regulatory data for PV reporting
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 Technical/Site Transfer Applications
Assisting with the preparation of Marketing Authorisation Applications
Ensuring compliance with all regulatory processes, in readiness for both internal and external audits.
Ensuring compliance with the regulations of the assigned Countries within Australia Region
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:
Experience of Medical Devices would be beneficial
Experience of other EU region would be beneficial
Previous experience of people management/coordination would be an advantage
Experience of PV would be beneficial
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 [insert area]
Job Type: Full-time
Pay: $54,155.78 – $100,000.00 per year
Schedule:
10 hour shift
Work Authorisation:
Australia (Preferred)
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