Responsable Affaires Pharmaceutiques senior
Core
Senior Pharmaceutical Affairs Manager responsible for regulatory, quality, and distribution activities for a pharmaceutical portfolio.
Role type
Senior Pharmaceutical Affairs Manager
Builds
Regulatory submissions, quality management systems, and product distribution for rare disease therapies
Domain
Biopharmaceuticals, Rare Diseases
Deliverable
client delivery
Required skills
Regulatory affairs management, Pharmacovigilance coordination, Quality assurance audits, Distribution logistics, Stakeholder management with health authorities, Advanced English
Preferred skills
Master's degree in Regulatory Affairs, Experience with MARR measures, Hospital and pharmacy network coordination
Technologies
None stated
Responsibilities
Coordinate local AMM (marketing authorization) dossiers, Ensure regulatory compliance for product labeling and packaging, Manage pharmacovigilance and medical information projects, Validate promotional and institutional communication materials, Oversee quality reviews and internal/external audits, Coordinate drug lot availability and interactions with hospitals and pharmacies
Seniority
Senior, hands-on IC