Principal Regulatory Affairs Specialist

Our client, a major multinational here in Galway, is looking to hire a Principal Regulatory Affairs Specialist on an initial 12-month contract.
Responsibilities: Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of the company, internal audits, and inspections.Leads or compiles all materials required in submissions, license renewal, and annual registrations.Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance. Monitors and improves tracking/control systems.Keeps abreast of regulatory procedures and changes.May direct interaction with regulatory agencies on defined matters.Recommends strategies for earliest possible approvals of clinical trials applications.Requirements: Requires a University Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.May have broad knowledge of project management.Requires mastery of a specialty area and full knowledge of industry practices, typically obtained through advanced education combined with experience.For more information and a confidential discussion on the role, please contact Michelle Mc Inerney. ****** 091 706717

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