Reporting to the Head of Quality & Regulatory Affairs France / BeNeLux – Pharmacien Responsable, the
Regulatory Affairs & Quality Assurance - PRI support the Exploitant for :
> Exploitant Quality Assurance
› Taking part into the implementation, maintenance and improvement of the Quality Management System (QMS) of
VALNEVA France SAS in line with the Group Quality Policies, GMP/GDP&GVP guidelines and Public Health Code,
› Participating to training program of the affiliate‘s personnel,
› Contributing to continuous improvement of the Exploitant through risk analysis,
› Managing deviations/CAPAs/Change control,
› Managing Product Technical Complaints (PTC)
› Participating to Self-inspections/internal and external audits,
› Managing suppliers qualification/monitoring,
› Assisting the PR for products recall, and the potential cases of counterfeited products,
› Approve any returns to saleable stock if need be,
› Participate to inspection readiness,Taking part into Management Review and Quality Risk Management
› Reviewing the Product Quality Review
> Regulatory affairs
› Managing the MA lifecycle of the marketed products
› Reviewing packaging material of the product intended to be market on the territory,
› Performing Regulatory Intelligence,
› Assisting the PR in the management of out of stock situation,
› Set up MITM analysis and PGP, if applicable
› Monitor shortage situation.
> Pharmaceuticals responsibilities
› Assuming pharmaceutical responsibility in the planned/unplanned absence of the Pharmacien Responsable.
> General support
› Promoting Exploitant regulation approach with internal and external stakeholders and control its implementation,
› Developing trusting professional relationship with governmental authorities
✓ Graduated Pharmacist,
✓ At least 3 years of experience in a Pharmaceuticals Exploitant
✓ Experience compliant to article R.5124-16, R.5121-164 of French health code,
✓ Registered/registrable at the College of Pharmacists section B as Pharmacien Responsable Intérimaire Exploitant.
✓ Ideally a master degree in regulatory/quality affairs
✓ Fluent in English, both written and spoken,
✓ Solid knowledge of GxP and Exploitant regulation
✓ High sense of responsibility,
✓ Excellent management and organizational skills,
✓ Ability to make decisions including in stressful situation,
✓ Sense of priority and deadlines,
✓ Perfect understanding of potential public health issues related to activity,
✓ Ability to demonstrate independence, objectivity, ethics and confidentiality