- Company Name
- Cytokinetics
- Job Title
- Pharmacien Responsable/ Directeur des Affaires Pharmaceutiques
- Job Description
-
**Job title**
Pharmacy Director / Director of Pharmaceutical Affairs
**Role Summary**
Lead regulatory, quality, pharmacovigilance, and compliance functions for the French subsidiary of a specialty cardiovascular biopharma company. Build and maintain the legal operating status (ANSM), implement a local QMS, develop SOPs, manage regulatory filings, oversee medical information, and coordinate audits and inspections. Serve as the central liaison between EU headquarters, global teams, and French health authorities.
**Expectations**
- Secure local operating license and maintain regulatory status.
- Establish a compliant quality system that satisfies GxP, EMEA, and French standards.
- Ensure timely submission and renewal of INDs, marketing authorisations, and related documents.
- Maintain active pharmacovigilance processes with EU PV coordination.
- Lead internal and external audit readiness and close corrective actions.
- Represent the company in French professional bodies and maintain certifications.
**Key Responsibilities**
- Compile and submit the ANSM dossier for obtaining operating status (documents, technical data, regulatory compliance).
- Design, implement, and maintain a local QMS (policy, organization, document control, CAPA, supplier management, training).
- Draft, validate, deploy, and update SOPs for pharmacovigilance, product complaints, recalls, GDP transport/ storage, medical information, promotion, and training.
- Manage local regulatory activities: IND/MAM filings, label and package leaflet in French, regulatory surveillance, and interactions with ANSM and EU authorities.
- Coordinate local pharmacovigilance: case management, signal detection, PGRs, GVP audits, and external provider oversight.
- Supervise medical information service: process setup, scientific query handling, FAQ validation, EU‑global alignment.
- Lead audit and inspection preparedness: internal audits, ANSM inspections, CAPA implementation, continuous improvement.
- Ensure compliance with the Promotion Charter and Medical Visit Charter (LEEM), validate and monitor promotional material, train delegates, maintain IFIS reference.
- Engage with LEEM, IFIS, and sector working groups to monitor regulatory updates and ethical standards.
- Collaborate cross‑functionally with Medical Affairs, Market Access, Commercial, Supply Chain, Regulatory, and Legal to maintain product and communication compliance.
- Oversee early access programs in partnership with Clinical Development, R&D, and Market Access teams; interact with ANSM, physicians, and pharmacists.
- Manage external service providers (quality consultants, QP, logistics, distribution).
- Deliver regular compliance reporting (KPIs, audits, incidents, CAPA, PV, inspection readiness) to French and European leadership.
**Required Skills**
- Deep knowledge of French drug regulatory framework (ANSM, ANMAT‑IREM, SDC, EUR‑MP).
- Expertise in GxP quality systems, SOP development, CAPA, change control, document control.
- Proven experience in pharmacovigilance management and GVP compliance.
- Strong audit and inspection oversight, including CAPA turnaround and continuous improvement.
- Ability to manage medical information processes and promotional compliance (LEEM, IFIS).
- Excellent project management, cross‑functional coordination, and stakeholder communication.
- Proficiency in French (reading, writing, speaking) and strong written English.
**Required Education & Certifications**
- Pharm.D. or equivalent (Pharmacy degree).
- M.Sc./MBA or relevant advanced degree in Regulatory Affairs, Quality Management, or related field preferred.
- Certified Regulatory Affairs Professional (RAC) or equivalent (e.g., EU Regulatory Affairs Certification).
- Certified Quality Manager (CQE) or equivalent (e.g., ISO 9001 lead auditor).
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