Regulatory Affairs Specialist

Cosmoderma; Casalecchio di Reno; On-site; EUR 20,000 - 35,000; Full time

Job summary

Cosmoderma Commerciale S.r.l. is a cosmetics development and contract manufacturing company seeking a Regulatory Affairs Specialist to lead regulatory activities for products created for clients.

The role is based at the new office in the Meridiana district of Casalecchio di Reno with regular interaction with the San Benedetto Val di Sambro production site. The selected candidate will work closely with R&D, Sales, Graphic Design, Quality and Production teams, supporting product development from

Qualifications

• Degree in a scientific field such as Chemistry, Pharmaceutical Chemistry, Pharmacy, Biotechnology, or related discipline.
• Knowledge of Regulation (EC) No. 1223/2009 on cosmetic products.
• Familiar with cosmetic technical documentation: PIF, CPSR, CPNP, claims, and labelling.
• Strong Microsoft Office skills.
• High accuracy, organisational skills and attention to detail.
• Fluent English, minimum C1; C2 advantageous.

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 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.

Skills

Regulatory knowledge

Cosmetics docs

Microsoft Office

Accuracy & detail

English fluency

Education

Science degree in Chemistry or related

Tools

Microsoft Office

Job description

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.

Main Responsabilities

• 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.