URIACH REGULATORY AFFAIRS SPECIALIST (FRENCH NATIVE) Envie

Responsibilities

• Support for new projects in collaboration with R&D, Marketing and Project Management
• Review of possible claims and communication opportunities for new projects or products already in the market
• Establish synergies between the different local regulatories with a global approach for the development of any new project.
• Ensure regulatory compliance of all the products (ingredients permitted, allowed quantities, etc...) in local and global formulations.
• Control and adaptation to new regulations.
• Preparation of packaging texts, review of proposal and approval of final artworks.
• Coordinate between the different local regulatories for the multilingual packaging project.
• Supervision and/or preparation PIF, TD, eCTD dossiers. Life cycle maintenance of these dossiers.
• Registration and notifications tasks of different products (food supplements, cosmetics, medical devices or OTCs) prior to its commercialization.
• Request of different national codes required for commercialization.
• Verification of the communication of marketing materials, websites, etc...
• Direct contact with Regulatory bodies and consultants.
• Direct contact with RoW partners to provide all the information and documents necessary for registration of products abroad.
• Post-market surveillance activities for medical devices. Coordinate with PV department for OTCs and medical devices.
• Management of information (databases, SOPs...) according applicable ISO requirements (22000, 14001, 13485...)