REGULATORY AFFAIRS PROJECT MANAGER M/W (FR)
Doctorat en :
PharD, PhD in Science
Worldwide leading pharmaceutical company, specialized in R&D, production and sale of innovative solutions in dermatology
Résumé de la fonction :
In agreement with your Team leader, you will ensure the international coordination of projects in development for the regulatory activities (EU, USA, Japan and emerging countries).
Description de la fonction :
• Regulatory support for projects in development: As representing RA within project teams and steering committees, you propose regulatory strategy and consulting authorities for projects in development and coordination of these consultations, you perform analysis of the regulatory and competitive environment, contribute to the strategy of regulatory development, and bring your expertise in the interpretation of regulatory requirements and analysis issues.
• Preparation of files IND/CTA, Regulatory files (AMM…) and answers to questions: you contribute to the preparation of these files for accepting the request for approval and their coherence with strategy and objectives; you ensure the interface with Authorities during evaluation and work with the local RA managers and local regulatory representatives; you support these partners in the preparation and registration files for all markets.
• Management of the evaluation of the regulatory part during Due Diligences: you prepare recommendations on the regulatory aspect for products/folders study and evaluate the potential regulatory risks by region.
• Monitoring of the regulatory and distribution of relevant information to project team members and hierarchy.
Profil / Qualifications Requises :
PharD, PhD, MD, or eq., you have minimum 10 years’ experience in Regulatory Affairs in an international context, eventually completed by an experience in development or medical writing. You have good knowledge in non-clinical, clinical and pharmaceutical domains. Excellent analytical skills, excellent communication skills, good international relationship are required.
Fluent English and French.
Lieu de travail :
FRANCE - South France
Date de diffusion :
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