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Details

Senior Regulatory Compliance Officer


Reference:ALVY-285757 Location: Dublin
Qualification:DegreeExperience:3-4 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Regulatory Affairs, Regulatory Affairs Executive, Regulatory Affairs Officer, Regulatory Affairs Specialist

Senior Regulatory Compliance Officer
Our client, a global healthcare organisation, requires a Senior Regulatory Compliance Officer to join their team for fixed term contract, the duration of which is 6 months. The successful candidate will manage, review registration information and provide this information to relevant departments, and to ensure regulatory compliance for all products released.

Responsibilities
• Manage the review of registration information supplied by various regional registration centres and provide the information as appropriate to the relevant departments
• Manage the preparation, review and approval of Manufacturing and Analytical records and approval of External product documentation, in accordance with registered details
• Problem solving of regulatory compliance issues and implementation of CAPA’s arising from these
• Management of the compliance systems and implementation of improvement projects where necessary
• Coordinate the MRA Reduced Testing and Annex 16 Programmes
• Manage the Product Transfer and Product Launch compliance activities
• Manage change control and the registration variation process
• Track variations and maintain the variation tracker database identifying and addressing gaps in the system
• Liaise with central registration department to develop systems which help to improve the compliance systems and information received
• Manage site projects from a Regulatory Compliance perspective
• Mentor and train Regulatory Compliance officers
• Manage Reg Compliance actions for Launch and 3rd party requirements

Requirements
• 3rd level qualification in science related discipline
• 3 - 5 years’ experience within the pharmaceutical industry
• Relevant experience in regulatory or regulatory compliance group in a GMP/GLP environment is desirable
• Strong organizational skills / ability to prioritize work
• Proven track record as a team player
• High level of proficiency in Microsoft Word/Excel



If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252