REGULATORY AFFAIRS SPECIALIST (FRENCH NATIVE)Join to apply for the REGULATORY AFFAIRS SPECIALIST (FRENCH NATIVE) role at Uriach .
Key responsibilities include:
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 regulations 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 regulations 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...)
Seniority level: Entry level
Employment type: Full-time
Job function: Legal
Industries: Pharmaceutical Manufacturing
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