French Responsible Pharmacist: Regulatory Leader

Pharmanovia; France; Sur place; EUR 120 000 - 170 000; Plein temps

Résumé du poste

Pharmanovia France seeks an experienced Responsible Pharmacist to lead all pharmaceutical operations, ensuring compliance with French and European regulations and safeguarding product quality. You will oversee regulatory affairs, quality, pharmacovigilance, and supply continuity while partnering with senior leadership.

The role requires extensive experience as a Pharmacist Responsable, strong governance, and collaboration with ANSM and other regulators to support the company’s growth in France.

Qualifications

• Qualified Pharmacist eligible to act as Pharmacien Responsable under French legislation.
• Registration with the Ordre National des Pharmaciens (or eligibility).
• Advanced knowledge of French pharmaceutical legislation and European regulatory requirements.
• Degree in Pharmacy (PharmD or equivalent recognised in France).
• Significant experience as a Responsible Pharmacist or Deputy Responsible Pharmacist.
• Extensive experience in pharmaceutical operations in France.
• Experience managing regulatory compliance for manufacturers, MAHs or operators.
• Experience interacting with ANSM and other regulatory authorities.

Responsabilités

• Act as the legally appointed Responsible Pharmacist for Pharmanovia France, ensuring full compliance with the French Public Health Code.
• Provide overall responsibility for all pharmaceutical operations, including regulatory compliance, quality assurance, pharmacovigilance, distribution and batch recall activities.
• Ensure continuous supply of Pharmanovia medicines to the French market by proactively managing supply risks and shortages.
• Lead the pharmaceutical quality management system (PQS) with ongoing improvements.
• Ensure GDP, GMP and pharmacovigilance compliance and maintain inspection readiness.
• Review, approve and sign regulatory submissions, including MAAs.
• Provide strategic regulatory leadership throughout the product lifecycle.
• Monitor changes in legislation and implement compliance measures.
• Lead and mentor delegated pharmacists and pharmacy personnel.

Connaissances

Qualified Pharmacist

Regulatory compliance

Pharmacovigilance

GDP/GMP knowledge

Leadership/mentoring

Stakeholder management

Regulatory submissions

Formation

Pharmacy degree (PharmD or equivalent)

Registration with Ordre National des Pharmaciens

Description du poste

Pharmanovia France seeks an experienced Responsible Pharmacist to lead all pharmaceutical operations, ensuring compliance with French and European regulations and safeguarding product quality. You will oversee regulatory affairs, quality, pharmacovigilance, and supply continuity while partnering with senior leadership.

The role requires extensive experience as a Pharmacist Responsable, strong governance, and collaboration with ANSM and other regulators to support the company’s growth in France.