Responsible Pharmacist

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 is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 160 markets. Our mission is to improve patient health globally by revitalising niche, trusted medicines across our core therapeutic areas: Cardiovascular, Oncology, Endocrinology, and Neurology. Since our founding in 2013, we’ve grown consistently by delivering high-quality branded prescription medicines to patients, prescribers, and healthcare providers worldwide. Our global team of over 300 employees across 29 nationalities operates from offices in the UK, Denmark, the Netherlands, Switzerland, Italy, Spain, Germany, the UAE, India, Australia and Singapore.

We are looking for an experienced Responsible Pharmacist (Pharmacien Responsable) to lead and oversee all pharmaceutical operations for our French legal entity. This is a highly strategic leadership role with statutory responsibility under the French Public Health Code, acting as the company’s legally appointed Responsible Pharmacist. You will ensure that all pharmaceutical activities are conducted in full compliance with French and European regulatory requirements while safeguarding product quality, patient safety and supply continuity. You will work closely with senior leadership and cross-functional teams across Regulatory Affairs, Quality Assurance, Supply Chain, Medical Affairs, Pharmacovigilance, Commercial and Global Operations to ensure the highest standards of regulatory compliance and operational excellence. This position plays a critical role in supporting Pharmanovia’s continued growth in France while maintaining our commitment to quality, compliance and patient care.

• Act as the legally appointed Responsible Pharmacist for Pharmanovia France, ensuring full compliance with the French Public Health Code and all applicable pharmaceutical legislation.
• Provide overall responsibility for all pharmaceutical operations, including regulatory compliance, quality assurance, pharmacovigilance, distribution, importation, exportation, product storage, transportation and batch recall activities.
• Ensure a continuous, uninterrupted supply of Pharmanovia medicines to the French market by proactively managing supply risks, shortages, and emergency supply requirements.
• Lead the pharmaceutical quality management system (PQS), ensuring continuous improvement through quality reviews, compliance monitoring and robust governance processes.
• Ensure full compliance with Good Distribution Practice (GDP), Good Manufacturing Practice (GMP) and pharmacovigilance requirements, maintaining inspection readiness at all times.
• Review, approve and sign regulatory submissions, including Marketing Authorisation Applications (MAAs) and other submissions requiring Responsible Pharmacist approval.
• Provide strategic regulatory leadership throughout the product lifecycle, including new product introductions, variations, and post-approval activities.
• Ensure product integrity throughout the supply chain, verifying that storage, transportation and distribution conditions meet all regulatory and quality requirements.
• Oversee pharmacovigilance governance, including delegation of pharmacovigilance activities to the appointed Local Qualified Person for Pharmacovigilance (LQPPV) or Head of Pharmacovigilance where appropriate.
• Lead quality management reviews, analysing Annual Product Quality Reviews (APQRs) and ensuring appropriate follow-up with manufacturing partners.
• Oversee investigations relating to quality defects, counterfeit medicines, falsified products and product complaints, ensuring timely reporting to the French Health Authority (ANSM).
• Ensure compliance with the EU Falsified Medicines Directive (FMD), including verification of safety features and reporting of suspected falsified medicines.
• Maintain oversight of pharmaceutical partners, including manufacturers, contract organisations, distributors and logistics providers to ensure continued regulatory compliance.
• Provide pharmaceutical oversight for commercial operations, ensuring promotional activities comply with the French Promotional Charter and HAS Certification requirements.
• Participate as a permanent member of the company's senior leadership discussions, providing pharmaceutical expertise on strategic business decisions affecting regulated activities.
• Build strong relationships with French regulatory authorities, including the ANSM and the National Order of Pharmacists, acting as the primary pharmaceutical representative for the organisation.
• Monitor changes in French and European pharmaceutical legislation, assess business impact, and implement appropriate compliance measures.
• Provide expert guidance to executive leadership regarding regulatory risks, compliance obligations and pharmaceutical governance.
• Lead, mentor and support delegated pharmacists and pharmacy personnel, ensuring appropriate delegation of responsibilities and professional development.

Qualifications

• Qualified Pharmacist eligible to act as Pharmacien Responsable under French legislation.
• Registration (or eligibility for registration) with the Ordre National des Pharmaciens.
• 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 within the pharmaceutical industry.
• Extensive experience working within pharmaceutical operations in France.
• Strong experience managing regulatory compliance for pharmaceutical manufacturers, MAHs or pharmaceutical operators.
• Demonstrated experience working within GDP- and GMP-regulated environments.
• Proven experience overseeing pharmacovigilance, quality systems and pharmaceutical governance.
• Experience interacting directly with ANSM and other regulatory authorities.
• Experience supporting inspections, audits and regulatory submissions.
• Experience managing pharmaceutical supply continuity and shortage management.
• Strong experience working with Contract Manufacturing Organisations (CMOs), logistics providers and third-party distributors.
• Experience leading multidisciplinary teams within regulated pharmaceutical environments.
• The successful candidate will demonstrate expert knowledge of:
• French Public Health Code.
• European pharmaceutical legislation.
• Good Manufacturing Practice (EU GMP).
• Good Distribution Practice (GDP).
• Pharmacovigilance regulations.
• Quality Management Systems.
• Marketing Authorisation procedures.
• Batch recalls and quality defect management.
• Pharmaceutical supply chain

Why Join Pharmanovia?

Joining Pharmanovia means becoming part of a growing international pharmaceutical company where quality, innovation and patient care are at the centre of everything we do.

We offer:

• A senior leadership position with significant strategic influence.
• The opportunity to shape pharmaceutical operations across France.
• A collaborative and entrepreneurial international culture.
• Career development within a rapidly expanding organisation.
• Competitive salary and comprehensive benefits package.
• The opportunity to make a meaningful impact on patient access to medicines across France.

If you're an experienced Responsible Pharmacist seeking a highly visible leadership role that combines regulatory excellence with strategic influence, we'd love to hear from you.