Cache of job #13651083

Job Title

Regulatory Affairs Officer

Employer

Hartley People

Location

Kilkenny, Waterford, Tipperary

Description

Our client, a leading pharmaceutical client based in Waterford currently has a requirement for a Regulatory Affairs Manager. This role would suit someone with previous pharmaceutical experience. Experience in regulatory affairs is desirable. General Overview: To Support the Regulatory Affairs Manager with activities associated with the registration of the companies/OPKO's products in worldwide markets including US, EU and Japan, as well as Regulatory compliance liaison with QA for registered products. Support activities for running Bioequivalence and Clinical safety and efficacy studies. The Role: Licence maintenance support to customers, the company's regulatory agents and internal departments within the company itself. Regulatory Compliance liaison with QA. Support licensing activities for existing Marketing Authorisation applications in Europe, US, Japan, Canada and various markets in South America, Asia and the Middle East. Dossier preparation for submission to all company target markets, including liaison with R&D, QC, and Production as well as external experts where required. Strategic planning of regulatory activities in target markets for the company's products. Support activities in the areas of Bio-equivalence and Clinical safety and efficacy study management. Minimum Qualifications & Experience: Minimum B.Sc. or a third level qualification required, preferably in Chemistry, Pharmacy or Pharmacology. Previous pharmaceutical experience required; regulatory affairs experience desirable. Hartley People Recruitment work to the highest ethical standards within our industry and we value the trust that you place in us when you send your CV. If you meet the criteria for this position, we will provide a full consultation in confidence and we guarantee that your CV will not be sent to any of our clients without your consent. For immediate consideration please call Eamonn on 051-878 813 or email your CV in response to this job posting.

Date Added

2628 days ago

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