Responsibilities

• Préparer ou revoir les documents réglementaires CMC (Module 3 complet, Quality Overall Summary, IMPD, dossiers de variation).
• Définir les stratégies de rédaction des documents.
• Définir les positionnements pour les dossiers de variation.
• Evaluer la conformité des documents CMC en fonction de l’état de l’art, des guidelines en vigueur, des exigences locales et des directives client en réalisant des Gap analysis de documents réglementaires.
• Conseille en développement pharmaceutique : analyse de rapports de validation, de formulation ou de stabilité.
• Proposer des stratégies de formulation, de validation, de choix de spécifications, de plan de stabilité, de bioéquivalence.
• Pouvoir analyser et/ou rédiger des rapports scientifiques à partir des données brutes transmises.
• Regulatory compliance: be able to compare analytical techniques and / or manufacturing process between MA file and factory procedures.
• Carry out a continuous regulatory watch and communicate them to the teams.
• Contribute to the support and training of newcomers and their colleagues (methodology, feedback, tools).
• Apply internal processes and templates as well as best practices in the profession
• Report any deviation or problem to their manager and propose corrective or preventive actions

Education and Experience

A pharmacist / engineer / bac +5 type diploma with a minimum or equivalent justifying 5 years of significant experience or Project Manager in the field in question.

Prior knowledge of the pharmaceutical industry is required

Skills

• Work in a team, collaborate and cooperate with others
• Develop positive contacts with the work environment
• Constantly seek to optimize their knowledge and skills
• Propose alternative solutions to optimize the efficiency of the activity and the satisfaction of internal / external customers
• Adapt, be open to change
• Demonstrate rigor
• Be organized
• Pragmatism: knowing how to reconcile an ideal vision with the critical constraints of the client
• Leadership: knowing how to conduct a meeting and bring participants together towards a consensus
• Give a good image of the company
• Fluency in written and oral English for daily contacts, other languages ​​would be a plus