Regulatory Affairs Specialist

Cosmoderma; Casalecchio di Reno; In loco; EUR 20.000 - 35.000; Tempo pieno

Descrizione del lavoro

Cosmoderma Commerciale S.r.l. is seeking a Regulatory Affairs Specialist to lead regulatory documentation for cosmetic products developed and manufactured for clients, ensuring compliance across markets.

The role is based at the new office in the Meridiana district of Casalecchio di Reno, with close collaboration with production and other departments to support product development from formulation to market launch and regulatory activities in EU and non-EU markets.

Competenze

• Degree in a scientific field with regulatory knowledge for cosmetics.
• Knowledge of Regulation (EC) No. 1223/2009 and cosmetic documentation (PIF, CPSR, CPNP).
• Strong attention to detail and accuracy; fluent English (C1+).
• Experience with EU and non-EU regulatory processes preferred.

Mansioni

• Lead regulatory affairs function and documentation for cosmetic products.
• Prepare and review PIF, CPSR, CPNP and labeling claims.
• Coordinate regulatory priorities with other departments.
• Support QA with audits and regulatory documentation.
• Communicate with clients, labs, consultants and safety assessors.

Conoscenze

Regulatory affairs

Regulatory documentation

Attention to detail

English proficiency

Project coordination

Formazione

Science degree (Chemistry/Pharma/Biotech)

Strumenti

Microsoft Office

Descrizione del lavoro

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 position will be based at our new operational office in the Meridiana district of Casalecchio di Reno, with regular interaction with the company’s production site in San Benedetto Val di Sambro.

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.

• 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 relating to raw materials, packaging and finished products
• Communication with clients, external laboratories, consultants and safety assessors
• Regulatory support for products intended for EU and non-EU markets
• Support to the Quality Management System in relation to 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 a related discipline
• 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 a strong advantage

Preferred qualifications

• Previous experience in the cosmetic industry
• Experience in contract manufacturing or private-label cosmetics
• Knowledge of non-EU cosmetic regulations, particularly the US market and MoCRA

Soft Skills

• Ability to manage multiple projects simultaneously
• Good communication and interpersonal skills
• Cross-functional collaboration mindset
• Autonomy and sense of responsibility
• Practical, structured and solution-oriented approach
• Understanding of roles, responsibilities and organizational dynamics

Employment conditions

Gross Annual Salary range: €20,000 - €35,000, depending on experience and skills.