Regulatory Affairs Specialist

17 ago - Bologna
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 lev

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