Descrizione della posizione:
Technical Skills
The 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 requests
* Prepare Margins of Safety (MOS) request and submit them to the safety assessor
* Select 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 them
* Check finished products labelling regarding the regulation in force
* Gather all documents for CPSR requests and ask for CPSR
* Register CPNP notifications where relevant
* Gather all data and documents needed in the Product Information File, OTC reports and specifications for sending to the customers and archive them
* Update CPSR, MOS, PIF/OTC reports and Specifications for existing products following the regulations in force in the case of change controls
* Follow new developments, answering to customers requests or local authorities and gathering complementary data if necessary
* Be regulatory support for customer’s registrations and legalizations
* Ensure Regulatory, scientific and technologic watch for Europe and International countries
* Manage regulatory watch on going topics when necessary
* Can participate to webinars, Regulatory exhibitions
* Participate in building and maintenance of regulatory database. Ensure that the data
* entered is accurate and justified to improve data centralization
Project Management
* Follow 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 planning
* Prepare and submit the technical agreement to the Project Managers to define RACI linked to the development
Hard Skills
* Background: Master in science with experience in Cosmetic Regulatory
* SOP & 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 use
* TOXICOLOGICAL KNOWLEDGE
Soft Skills
* Rigor/Attention to detail, Adaptability, Collaboration, Organization, Communication, Customer
* service, Lean oriented, Team spirit
Please send your CV in English