Regulatory Affairs Officer
March 2014 — Present
To support the Regulatory Affairs Manager and Head of Regulatory and Clinical Affairs with activities associated with the registration of medicinal products in Worldwide markets including US, EU and Japan, as well as Regulatory compliance with Quality Assurance for registered products.
Support activities for running Bioequivalence studies.
• License maintenance support to customers and internal departments within EirGen
• Support licensing activities for existing Marketing Authorisation Applications in Europe, Japan, US, Canada and various markets in South America, Asia and the Middle East.
• Dossier preparation for submission to all EirGen target markets, including liaison with Research and Development, Quality Control and Production as well external experts
• Strategic planning of regulatory activities in target markets for EirGen's products
• Monitoring of Bio-equivalence studies