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