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
Valneva is a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs.
We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.
We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines, including the world’s first and only chikungunya vaccine, as well as certain third-party vaccines.
Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, as well as vaccine candidates against the Zika virus and other global public health threats.
Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with approximately 700 employees.
