Regulatory Affairs Specialist

31 ago - Roma
Cosmoderma

Cosmoderma Commerciale S.R.L. is a company specialized in the development and contract manufacturing of cosmetic products.
We are looking for a Regulatory Affairs Specialist to manage our Regulatory Affairs function and ensure the correct handling of technical and regulatory documentation for cosmetic products developed and manufactured for our clients.
The selected candidate will initially work alongside the current Regulatory Affairs Manager, gradually becoming the main point of reference for regulatory matters within the company. The role will involve close collaboration with R&D;, Sales, Graphic Design, Quality and Production teams, supporting product development projects from the formulation stage through to market launch.
Main responsibilities
Management of the Regulatory Affairs function
Preparation, review and management of regulatory documentation for cosmetic products
Management and verification of Product Information Files (PIF)
Support with CPNP notifications
Review of claims, labels, artworks and product texts from a regulatory perspective




Collection and verification of technical documentation related to raw materials, packaging and finished products
Communication with clients, external laboratories, consultants and safety assessors
Regulatory support for products intended for EU and extra-EU markets
Support to the Quality Management System for audits, procedures and regulatory documentation
Coordination of regulatory priorities in collaboration with the other company departments
Required qualifications and skills
Degree in a scientific field, preferably Chemistry, Pharmaceutical Chemistry and Technology, Pharmacy, Biotechnology or similar
Knowledge of Regulation (EC) No. 1223/2009 on cosmetic products
Knowledge of cosmetic technical documentation, including PIF, CPSR, CPNP, claims and labelling
Good knowledge of Microsoft Office
Accuracy, organizational skills and strong attention to detail
Fluent English, minimum C1 level;
C2 will be considered astrong

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