Regulatory Affairs Controller

ICDS Recruitment

Waterford

Regulatory Affairs Controller - County Waterford. Job Purpose: To support the Regulatory Affairs Manager and Regulatory Affairs Officers with activities associated with the registration of company's products in worldwide markets including US, EU and Japan, as well as Regulatory compliance liaison with QA and Compliance for registered products. Key Responsibilities: • Licence maintenance support to customers, company's Regulatory agents and internal departments. • Regulatory Compliance liaison with all departments and department representative for compliance activities. • Regulatory compliance database and change control management. • Support licensing activities for existing Marketing Authorisation applications in Europe, US, Japan, Canada and various markets in South America, Asia and the Middle East. • Assist with dossier preparation for submission to all target markets. • Coordination of Regulatory Affairs Department, administration activities including: • Purchase order requisitions and receipt. • Document notarisation and legalisation. • Document preparation printing/scanning. • Maintenance of Regulatory hard and softcopy filing system. Minimum Qualifications & Experience sought: • Third level scientific qualification. • At least 12 months' experience in a GMP environment or relevant administrative experience. • Competent on Microsoft word, excel and project. Familiarity with cGMP in pharmaceutical manufacturing. Familiarity with concepts of Regulatory Approval process for pharmaceutical products. Working knowledge of EDMS (Electronic Document Management System. Project Management Skills. Competent in the use of Microsoft office. This job originally appeared on RecruitIreland.com.

2141 days ago