Posted: 12h ago
The role
Job DescriptionRegulatory Affairs SpecialistDuration: 12 MonthsLocation: GalwayResponsibilitiesDirects or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.Leads or compiles all materials required in submissions, license renewal and annual registrations.Recommends changes for labelling, 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.Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.May act as a mentor to colleagues or may direct the work of other lower-level professionals.The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies.Education & ExperienceRequires a University Degree and minimum of 2 years of relevant experienceWorks independently with general supervision on larger, moderately complex projects / assignments.***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
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