Pharmacien Affaires Réglementaires CDD 6 mois - Cardiovasculaire, Rénal et Métabolisme (F/H)
Core
Regulatory Affairs Pharmacist managing cardiovascular, renal, and metabolic product portfolios, handling registration dossiers, variations, renewals, and quality compliance for national and European markets.
Role type
Regulatory Affairs Pharmacist (Cardiovascular, Renal, Metabolic)
Builds
Regulatory dossiers, packaging updates, legal mentions, and quality management systems for pharmaceutical products.
Domain
Pharmaceutical industry, Regulatory Affairs, Quality Management
Required skills
Regulatory dossier preparation, stakeholder management with health authorities, packaging compliance, legal text writing, regulatory monitoring, quality system management, risk analysis, CAPA management, audit preparation, cross-functional collaboration.
Preferred skills
Strategic production and distribution planning, continuous improvement initiatives, external partner management.
Technologies
VIDAL monographies, ANSM, EMA, JORF, JOUE databases.
Responsibilities
Prepare and submit registration, variation, and renewal dossiers; serve as primary contact for health authorities; update packaging articles for compliance; monitor regulatory changes; contribute to quality strategy and distribution; disseminate regulatory information; participate in internal audits and inspections; manage quality indicators and deviations; oversee outsourced quality activities.
Seniority
Mid-level, hands-on IC