Pharmacien Affaires Réglementaires CDD 6 mois - Cardiovasculaire, Rénal et Métabolisme (F/H)
Core
Regulatory Affairs Pharmacist managing Cardiovascular, Renal, and Metabolism product portfolios, handling registration dossiers, quality compliance, and interactions with health authorities.
Role type
Regulatory Affairs Pharmacist (Contract)
Builds
Regulatory dossiers, packaging updates, quality procedures, and compliance documentation for pharmaceutical products.
Domain
Pharmaceutical Industry / Regulatory Affairs / Quality Management
Required skills
Pharmaceutical law, European and national registration procedures, packaging compliance, regulatory monitoring, quality management systems, CAPA management, risk analysis, stakeholder management, English fluency.
Preferred skills
Third-cycle legal or regulatory training, multi-project management, cross-functional collaboration.
Technologies
VIDAL, ANSM, EMA, JORF, JOUE databases and portals.
Responsibilities
Prepare and submit registration, variation, and renewal dossiers; act as primary contact for health authorities; update packaging articles and legal mentions; monitor regulatory changes; contribute to production and distribution strategy; disseminate regulatory information; collaborate with internal and external partners; update quality procedures; participate in internal audits and inspections; analyze quality indicators; manage deviations and risk assessments; oversee outsourced quality activities; implement continuous improvement plans.
Seniority
Mid-level, hands-on IC