Significant experience in Romanian Regulatory Affairs and, ideally, coordinating workload and activity management.
Required Education
Degree in relevant life science discipline
Required Experience
5-8 years relevant experience
Required Technical Skills
Minimum 5 years experience in RO Regulatory Affairs (e.g. Product Life cycle management, new MAA, Orphan Drugs, Line extensions, Product Information updates, Linguistic review, Artwork review)
Able to monitor and maintain up-to-date knowledge of national and European guidelines/legislation.
Experienced in interaction with HA
Able to ensure compliance with:
all regulatory processes, in readiness for both internal and external audits.
the regulations of assigned Countries
client processes
skilled in the use of 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
Ability to keep activities and resources overview
Experience with training / mentoring junior members
Good grasp of financial aspect of BU activities
Carry out periodic reviews and activity monitoring for transmission to clients.
Monitor quality indicators.
Manage the drafting of quality provisions.
Ensure the follow-up of the CAPAs.
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