Description de l'emploi - REGULATORY AFFAIRS SPECIALIST
Our client is an innovative company active in the health/well-being sector, with a strong entrepreneurial mindset. While being an international company, it is still a fun family-like structure, where you will be reporting directly to the three founding partners of the company. You will be given the opportunity to work within a company experiencing a real revolution thanks to its success.As a Regulatory Affairs Specialist, your main tasks will be : - manage all product regulatory aspects of the company in Europe, for own distribution and with European distributors, directly and/or with Consultants,- progressively manage, with Distributors/Consultants, product regulatory matters outside Europe,- provide regulatory inputs to product development, in coordination with Supply Chain Manager and the scientific team,- monitor evolution in regulatory environments (cosmetics, biocide, medical device),- provide regulatory inputs for positioning of new products,- coordination of relevant tests,- constitution and maintenance of regulatory database for each product,- select regulatory advisers and manage relationships with them,- manage relationship with regulatory bodies, either directly or through advisers,- regulatory validation of packaging, brochures, sales support documents, websites and FDS,- prepare/coordinate all filings with regulatory bodies in Europe, and progressively outside Europe,- coordinate potential issues, - issue certificates when needed,- prepare statistics when required.Additional tasks:Support in preparation/maintenance of ISO files,Support in preparation of environment audits,Administration other than sales administration.
