Pharmaceutical Affairs Manager/ Deputy Responsible Pharmacist, France & Benelux

Position Summary: ultrafocused – Work together to fearlessly uncover new possibilities Working directly with the Responsible Pharmacist & Director of Pharmaceutical Affairs France & Benelux, the Pharmaceutical Affairs Manager / Deputy Responsible Pharmacist, will manage the quality system and ensures compliance with applicable pharmaceutical regulations for the French & Benelux cluster. This position will require close collaboration with the European Qualified Person and Global QA. Work Model: Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site and thus will be subject to certain on-site safety protocols during the pandemic. Responsibilities: Manage and maintain the Quality System for the Cluster Ensure compliance of promotional activities to applicable standards (e.g. LEEM Charte, HAS reference standards,…) Definition, implementation, monitoring of audits plan and monitoring of subcontractors involved in pharmaceutical activities Ensure readiness for Inspections by competent authorities or audits Ensure deviations, change controls, risk assessments, CAPAs, recalls and product returns, batch tracking are processed and tracked accordingly Review packaging materials, promotional and non-promotional materials Coordinate initial and continuous training for employees, including tracking, monitoring of knowledge acquisition and archiving Serve as a backup for additional responsibilities the Pharmaceutical Affairs department. In addition, the Pharmaceutical Affairs Manager will act as Deputy Responsible Pharmacist, to cover periods when the Responsible Person is unavailab According to article R-5124-34 and R- 5124-36 of the French Public Health Code, the Responsible Pharmacist position covers a broad area of responsibilities as Regulatory (Marketing Authorization and labelling), Quality (Complaints, Batch traceability and batch recalls, Manufacturing/Distribution/Storage/Transport of medicinal products), Import/Export activities, Pharmacovigilance, Advertising, Medical information related to the "Exploitant" status and participation in Research & Development activities. Requirements: Pharmacist diploma, with fluent French and English language skills. Qualification as Deputy Responsible Pharmacist and at least 2 years’ experience in that role. 5-10 years' experience in Quality Assurance 6-12 months experience in Pharmacovigilance and batches follow up. Knowledge of GxP's, with a high focus on French and European regulations, GMP, GDP and GVP. Travel