Technical Director – Responsible for Approvals and Registrations
Sarl DENTINA
Posted on 23 Oct
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Nationality
Any Nationality
Gender
Not Mentioned
Vacancy
1 Vacancy
Job Description
Roles & Responsibilities
Missions
Manage and supervise the approval, registration and regulatory compliance processes for health products with the Ministry, in order to ensure their marketing in compliance with current regulations.
Approval and registration.
Regulatory Watch.
Internal and External Coordination.
Management et Reporting.
Profile
Bac +5 or more in pharmacy.
Minimum 2 years of experience in a similar role, ideally in the pharmaceutical or medical device sector.
Solid experience in relations with health authorities (notably the Ministry of Health).
Excellent knowledge of national (and international if applicable) regulations.
Mastery of the constitution of marketing authorization files and registration procedures.
Knowledge of quality assurance and regulatory documentation management.
Behavioral skills.
Rigor, organizational skills and analytical mind.
Communication and negotiation skills.
Leadership and team spirit.
Desired Candidate Profile
- Bac +5 ou plus en pharmacie.
- Minimum 2 ans d exp rience dans une fonction similaire, id alement dans le secteur pharmaceutique ou des dispositifs m dicaux.
- Solide exp rience en relations avec les autorit s de sant (notamment le Minist re de la Sant ).
- Excellente connaissance de la r glementation nationale (et internationale si applicable).
- Ma trise de la constitution des dossiers d AMM et des proc dures d enregistrement.
- Connaissances en assurance qualit et gestion de la documentation r glementaire.
- Comp tences comportementales.
- Rigueur, sens de l organisation et esprit d analyse.
- Capacit s de communication et de n gociation.
- Leadership et esprit d quipe.
Company Industry
- Pharma
- Biotech
- Clinical Research
Department / Functional Area
- R&D
- Research & Development
Keywords
- Directeur Technique Charg Des Homologations Et Enregistrements
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Sarl DENTINA