Regulatory Affairs Officer

Key responsibilities

Your role as a Regulatory Affairs Officer will be to ensure that products that are registered, manufactured and/or distributed by the Infarama Customer, meet the required legislation.

• Assist and support the Regulatory Affairs department
• Prepare, verify and adapt product information
• Provide scientific support for marketing authorisation dossiers, notifications and technical dossiers
• Submit registration and notification dossiers to health authorities
• Manage the life cycle of the client portfolios (variations, renewals…)
• Proofread leaflets and labeling
• Evaluation of promotional activities
• Maintain records and files

Qualified/Responsible Person

Key responsibilities

Your role as a QP/RP will be to contribute to the implementation and optimization of projects of the infarAMA customers. You will be responsible for a variation of aspects within their projects such as:

• Accomplish QP/RP duties according to the applicable local and EU regulations (RD 14 Dec 2006 – GMP/GDP guidelines): manage and assure continuous improvement of the pharmaceutical quality management system (QMS) and handle quality complaints, rejects, reworks, returns, recalls, change control, deviations and CAPAs
• Batch certification (QP) and release for sale (RP) as primary and back-up QP/RP
• Perform GMP/GDP compliance gap analysis and interact with other departments
• Participate in GMP/GDP/QMS self-inspections and external audits
• Ensure inspection readiness and act as primary contact during Competent Authority inspections
• QA liaison with contract manufacturing organizations or third party logistic providers