Regulatory Affairs Specialist

Descrizione

Descrizione della posizione:Technical SkillsThe Finished Products Regulatory Affairs Specialist ensures the creation and administrative monitoring of all documents necessary for the company to comply with current cosmetic laws and regulations:Perform regulatory checks following Customers Banlist and international regulations regarding customers and internal briefs and requestsPrepare Margins of Safety (MOS) request and submit them to the safety assessorSelect external laboratories following liability, prices and delays in order to quote and organize safety and efficacy testings respecting product categories and claims.Plan, organize, gather and spread safety and efficacy testing results while helping interpretation of themCheck finished products labelling regarding the regulation in forceGather all documents for CPSR requests and ask for CPSRRegister CPNP notifications where relevantGather all data and documents needed in the Product Information File, OTC reports and specifications for sending to the customers and archive themUpdate CPSR, MOS, PIF/OTC reports and Specifications for existing products following the regulations in force in the case of change controlsFollow new developments, answering to customers requests or local authorities and gathering complementary data if necessaryBe regulatory support for customer’s registrations and legalizationsEnsure Regulatory, scientific and technologic watch for Europe and International countriesManage regulatory watch on going topics when necessaryCan participate to webinars, Regulatory exhibitionsParticipate in building and maintenance of regulatory database. Ensure that the dataentered is accurate and justified to improve data centralizationProject ManagementFollow all the steps of formula development in order to give regulatory support when needed to R&D laboratory, Sales Marketing and Project Managers.Respect leadtimes of development planningPrepare and submit the technical agreement to the Project Managers to define RACI linked to the developmentHard SkillsBackground: Master in science with experience in Cosmetic RegulatorySOP & IT tools expertise (ORACLE, COPTIS, Pack Office…)REGULATORY EXPERTISE (European and International regulatory, safety and efficacy testings)PROJECT DATA MANAGEMENT (RM, formula, packaging, testings…)Language: ENGLISH with professional useTOXICOLOGICAL KNOWLEDGESoft SkillsRigor/Attention to detail, Adaptability, Collaboration, Organization, Communication, Customerservice, Lean oriented, Team spiritPlease send your CV in English

Categoria: Legal