Pharmacien Responsable (H/F)

Description du poste et des missions

The company

Lucane Pharma, exploitant site based in Paris, is dedicated to developing and distributing medications tailored to treat rare diseases. Established in 2009, the French company is affiliated with Eurocept Pharmaceuticals Holding, a privately owned entity headquartered in the Netherlands. Eurocept Pharmaceuticals Holding is committed to streamlining the treatment process between medical professionals and their patients. Within Lucane Pharma, this entails expediting the regulatory approval process for its products to ensure they reach eligible patients as swiftly as possible, facilitating their availability and access to essential treatments.

The Position

We are seeking a Deputy Managing Director / Pharmacien Responsable Exploitant, eligible for registration to Ordre National des Pharmaciens.

Based in Paris, you will lead and manage the Lucane Pharma team, while performing all the duties of a Pharmacien Responsable for the entity. Being able to deal with the dotted line realities in the French office of employees in collaboration with the Dutch head office, you foster a collaborative and cohesive work environment within the Lucane Pharma team. You will closely collaborate with the CEO based in the Netherlands, and the Vice President Quality & Compliance for quality and compliance related activities. Your direct reporting line is to the VP Quality & Compliance with a dotted line to the CEO. For the Deputy Managing Director responsibilities you will report to the CEO.

This strategic position places you as a senior key member of the management, ensuring compliance of all pharmaceutical processes in France and drive a successful team.

Main Responsibilities:

Pharmacien Responsable of Lucane Pharma France.

As Pharmacist in charge, he/she guarantees  distribution of pharmaceutical products are in line with the GMP, GDP, GVP  and local French Health Authorities regulations (Code de la Santé Publique including articles R 5124.36 ; R5124-48-1 , R5124-48-2).

More specifically he/she:

• Take all necessary actions to maintain the effective and efficient “Exploitant” activities compliant with the GMP, GDP, GVP and also in a good level of efficiency.


• Update / Improve procedures and define new work instructions.


• Participate in the pharmaceutical development activities.


• Assures QA/AC and other pharmaceutical activities is of highest standards.


• Assures Pharmaceutical Department is involved in the relevant prioritized projects.


• Responsible of the commercialised batches (complaints, returns, recall).


• Responsible for the importation, exploitation, distribution, exportation activities in line with GDP/GMP and French regulations and regulations applicable in the country of destination.


• Responsible for PV activities and Medical Information. LPPV for France. As such, he complies with the obligations defined in article R5121-164 of the Public Health Code and work in close collaboration with EUQPPV.


• Responsible for the compliance for promotional compliance to the French regulation.


• Preparation and be responsible for Authorities inspections and audits.


• Inform Health authorities in case of any critical on the exploitated products that can impact patient’s safety.


• Responsible for the interaction with Health authorities in France.


• Ensure a continuous supply of the medicines to the hospitals and pharmacies in all relevant territories.


• Review of Lucane Pharma files submitted to the health authorities liaising with all actors (regulatory department, medical, marketing, partners, consultants, experts and health authorities).


• Responsible for the interaction with Health authorities in France.


• Follows up on various local laws and regulations in France.


• Assist for Pricing and reimbursement dossiers.


• Regulatory review of all medical materials.

Deputy Managing Director of Lucane Pharma France.

• Lead and manage the local team, fostering a collaborative and cohesive work environment being able to deal with the dotted line realities in the French office.


• Co-develop and implement strategic plans to enhance departmental performance and achieve business objectives.


• Drive innovation and entrepreneurial initiatives within the team to improve processes and outcomes.


• Mentor and develop team members, promoting continuous learning and professional growth.

What We Offer

• A strategic and high-responsibility position combining both national and international missions.


• A stimulating work environment within a young and dynamic team.


• Permanent, full-time contract (CDI) based in Paris (9ᵗʰ district). Regular travel to Eurocept International headquarters in the Netherlands is required.


• Benefits: health and life insurance, 75% coverage of public transport, meal vouchers.

Profil souhaité

Profile

• Qualified Pharmacist Registered to Ordre National des Pharmaciens and to Agence Nationale de Sécurité du Médicament et des Produits de Santé.


• Minimum 5 experience as PR within the pharmaceutical industry.


• Specialised in Regulatory and Quality.


• Bilingual communication skills (French/English), both oral and written.


• Energetic leader who has a passion to learn, grow and foster innovation and results.

Personal Qualities

• In-depth knowledge of national and international regulations and regulatory procedures, manufacturing processes, quality concepts.


• Affinity to multidisciplinary environment: chemistry, biology, medicines, pharmacology, toxicology, clinical development, marketing, sales, business management, and ability to work in multi-national / multi-cultural relationships.


• Strong business awareness and focus.


• Proficient and effective managerial, organizational, and communicative skills.


• Analytical, interpretative, evaluative and constructive mind.


• Fluency in written and spoken English.

Please submit your application to lfadl@lucanepharma.com

Informations du recruteur

Lieu de la mission