Senior Director, Responsible Pharmacist (Pharmacien Responsable), France
Core
Senior Director ensuring pharmaceutical responsibility and regulatory compliance for a late-stage oncology company's drug manufacturing, distribution, and safety operations in France.
Role type
Senior Director, Responsible Pharmacist (Pharmacien Responsable)
Builds
Oncology drug supply chain, regulatory filings, and safety monitoring for RAS-targeted therapies.
Domain
Biopharmaceuticals / Oncology / French Regulatory Affairs
Deliverable
client delivery
Required skills
French pharmacy doctorate, 15+ years leadership in oncology biopharma, regulatory affairs expertise, quality assurance, pharmacovigilance management, team leadership, French market knowledge
Preferred skills
Entrepreneurial environment experience, policy influence, cross-functional stakeholder management
Technologies
ANSM systems, EUDRAGMDP, PSUR databases, GMP/GDP frameworks
Responsibilities
Organize and supervise all pharmaceutical operations including manufacturing, distribution, and storage; ensure compliance with French Public Health Code and GMP/GDP; manage pharmacovigilance cases and adverse event reporting; lead the Pharmaceutical Affairs Department in France; oversee regulatory submissions and interactions with ANSM; approve promotional materials and medical information; manage batch release, recalls, and shortages.
Seniority
Senior Director, strategic leadership & operational oversight
