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, but not limited to Variations, Renewals, 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 the 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 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 :

EU (NP, CP, DCP, MRP, Worksharing) experience
Local IT, BE or CH experience
Previous experience of people management/coordination would be an advantage
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 European and International regions