Regulatory Affairs Specialist - Savona (SV) - Chromavis Fareva

Descrizione

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