Pharmacien Responsible/ Directeur des Affaires Pharmaceutiques at Cytokinetics

Paris, Île-de-France, France

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, PharmaceuticalIndustries

Requirements

Expertise in French pharmaceutical regulations, particularly with ANSM for establishment status and operator applications
Ability to define, structure, and deploy a local Quality Management System (QMS/PQS)
Proficiency in drafting, validating, deploying, and updating local SOPs across key areas (pharmacovigilance, product complaints, recalls, GDP, etc.)
Experience in managing local regulatory activities (AMM/variations, French labelling/notices, regulatory follow-up)
Knowledge of pharmacovigilance systems (case management, signal detection, PGR, GVP audits)
Skills in supervising medical information services (processes, scientific responses, FAQ validation)
Capability to prepare for and manage audits/inspections (ANSM, internal, providers)
Understanding of promotional compliance (Charte de l’Information Promotionnelle, Charte de la Visite Médicale, LEEM/IFIS standards)
Strong interaction skills with EU/global headquarters, French health authorities, and professional bodies (LEEM, IFIS)
Pharmacist qualification (implied by "Pharmacien Responsable")

Responsibilities

Elaborate and pilot the establishment file / operator status application with ANSM (organization, justifications, technical documents, regulatory compliance)
Define, structure, and deploy a local Quality Management System (PQS/QMS): quality policy, quality organigram, document control, change control, deviation/CAPA management, internal audits, supplier management, training plan, inspection preparation
Draft, validate, deploy, and update local SOPs covering essential areas: pharmacovigilance, product complaints, recalls/withdrawals, GDP transport/storage, provider management, medical information, promotion, training, documentation
Pilot and supervise local regulatory activities: AMM/variations, French labelling/notices, regulatory monitoring, interactions with ANSM and EU authorities
Establish and manage local pharmacovigilance in coordination with EU PV team: case management, signal detection, PGR, GVP audits, provider follow-up
Supervise medical information service: process setup, oversight of scientific responses, standard FAQ validation, coordination with EU/Global medical department
Act as key player in audits and inspections (ANSM, internal, providers): preparation, inspector hosting, CAPA responses, corrective action follow-up, continuous improvement
Ensure compliance of medical visit/promotional information activities per Charte de l’Information Promotionnelle / Charte de la Visite Médicale (LEEM): support validation/control, traceability monitoring, delegate training, IFIS referential compliance, legal obligations
Actively interact with external professional organizations (LEEM, IFIS) for regulatory monitoring, sectoral working group participation, charter updates, ethical vigilance
Serve as central point of contact between EU/global headquarters and French health authorities to ensure local compliance and support product launch, maintenance, and evolution
Lay foundations for regulatory, quality, pharmacovigilance, and compliance for local activities, including QMS/PQS setup, SOP deployment, medical IT and document management integration
Represent Cytokinetics in professional instances like LEEM and IFIS

Skills

Key technologies and capabilities for this role

Regulatory AffairsPharmacovigilanceQuality Management SystemSOP DevelopmentANSM ComplianceAuditsInspectionsMedical Information SystemsComplianceLabellingMarketing Authorization

Questions & Answers

Common questions about this position

What are the main responsibilities of this role?

The role involves setting up regulatory, quality, pharmacovigilance, and compliance foundations for Cytokinetics' French subsidiary, including preparing the ANSM dossier for operator status, deploying a local Quality Management System (QMS/PQS), writing SOPs, managing regulatory activities like AMM and labelling, and handling pharmacovigilance.

Is this position remote or office-based?

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

What reporting structure does this position have?

The position reports to the Directrice Générale France & Benelux, with a functional link to the Directrice Europe des Affaires Réglementaires.

What experience makes a strong candidate for this role?

Strong candidates will have expertise in French pharmaceutical regulations, experience with ANSM interactions, knowledge of QMS/PQS implementation, SOP development, pharmacovigilance, and regulatory affairs including AMM and labelling.

Cytokinetics

Develops drugs for muscle function disorders

About Cytokinetics

Cytokinetics focuses on developing medicines that improve muscle function for patients with cardiovascular and neuromuscular diseases. Their products are small molecule drugs designed to either enhance or inhibit muscle function, tailored to specific therapeutic needs. The company has a pipeline of drugs, including omecamtiv mecarbil and reldesemtiv, which are in various stages of clinical trials. Unlike many competitors, Cytokinetics emphasizes rigorous scientific research and has conducted over 50 clinical trials to ensure the effectiveness of its treatments. The goal is to bring new therapies to market that address the unmet needs of patients suffering from conditions like heart failure, ALS, and HCM.

South San Francisco, CaliforniaHeadquarters

1998Year Founded

$58.4MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

501-1,000Employees

Risks

Increased competition could impact market share and profitability.

Potential delays in clinical trials could hinder drug commercialization.

Dependence on strategic partnerships may expose Cytokinetics to risks if challenges arise.

Differentiation

Cytokinetics focuses on muscle activators and inhibitors for cardiovascular and neuromuscular diseases.

The company has a robust pipeline including omecamtiv mecarbil and aficamten.

Cytokinetics engages in strategic partnerships, like with Sanofi, to expand market reach.

Upsides

Recent investments indicate strong interest in muscle activators and inhibitors.

Strategic partnerships, like with Sanofi, expand market reach and potential revenue.

Significant funding from Royalty Pharma supports commercial launch and R&D advancements.

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