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 integral 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?)
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