Senior Regulatory Affairs Specialist

BO GROWTH; Monza; In loco; EUR 65.000 - 90.000; Tempo pieno

Vantaggi offerti da questo lavoro

International environment

Flexible starting time

On-site only work model

Descrizione del lavoro

BO GROWTH is seeking a Regulatory Specialist to lead regulatory and toxicological assessments for cosmetic products, ensuring compliance across markets. You will coordinate external consultants, maintain Product Information Files and monitor regulatory developments within a cross-functional team.

Ideal candidates hold a university degree in a related discipline, 5+ years in Cosmetic Regulatory Affairs, and fluency in Italian and English, with Spanish as a plus. On-site role in Lombardy, Italy.

Competenze

• University degree in Pharmacy, Chemistry, Biotechnology, Toxicology or a related discipline.
• Solid and up-to-date knowledge of European cosmetic regulations.
• 5+ years experience in Cosmetic Regulatory Affairs.
• Experience coordinating cross-functional teams and external consultants.
• Proficient Italian and English; Spanish would be an advantage.

Mansioni

• Lead and coordinate regulatory and toxicological assessments for cosmetics.
• Coordinate external consultants and regulatory projects with cross-functional teams.
• Maintain regulatory dossiers and Product Information Files (PIFs).
• Oversee safety dossiers and toxicological documentation prepared by external specialists.
• Manage regulatory notifications and product registrations in relevant markets.
• Monitor regulatory developments and their impact on the product portfolio.
• Act as a contact with authorities and regulatory bodies.
• Develop Regulatory Affairs activities within the team and allocate resources.

Conoscenze

Cosmetic regulations

Regulatory project management

Cross-functional coordination

Languages: Italian & English

Formazione

University degree in Pharmacy, Chemistry, Biotechnology, Toxicology or related discipline

Descrizione del lavoro

If you have experience in cosmetic regulations and enjoy coordinating regulatory projects with external partners and cross-functional teams, we would love to meet you

Our client:

Our client is an international company within the beauty industry, specialised in the development and manufacturing of innovative cosmetic solutions for leading market brands.

Role misson:

Reporting to the Regulatory Affairs leaders, the selected person will lead and coordinate regulatory and toxicological assessment activities for cosmetic products, ensuring compliance with the legislation applicable in all markets where the company operates.

The Regulatory Specialist will also coordinate external consultants and specialised providers, ensuring the efficient execution of regulatory projects, the quality of the technical documentation and compliance with deadlines and business priorities.

Key responsabilities:

• Ensure compliance with current cosmetic legislation, particularly Regulation (EC) No 1223/2009, as well as other applicable international regulations.
• Coordinate the preparation, review and maintenance of regulatory dossiers and Product Information Files (PIFs).
• Oversee product safety assessments and the corresponding toxicological documentation.
• Technically review and supervise safety dossiers and toxicological documentation prepared by external specialists.
• Manage regulatory notifications and product registrations in the relevant markets.
• Monitor legislative and regulatory developments and assess their potential impact on the company's product portfolio.
• Act as a key point of contact with competent authorities, industry associations and regulatory bodies.
• Coordinate and support the development of Regulatory Affairs and Toxicology activities within the team.
• Define priorities, allocate resources and monitor compliance with deadlines and objectives.
• Select, appoint and manage external consultancy firms specialising in regulatory affairs, toxicology, claims, product safety and other technical areas.
• Manage budgets associated with regulatory projects and external professional services.
• Analyse technical and regulatory documentation in depth and apply sound technical judgement when making decisions.
• Work closely with Project Managers, R&D, Quality, Marketing, Key Account Management, Procurement, Packaging, Design and Supply Chain teams.
• Ensure that new products are developed and launched in accordance with all applicable regulatory requirements.
• Contribute to the development of a growing Regulatory Affairs structure within an international and cross-functional environment.

What we are looking for:

• University degree in Pharmacy, Chemistry, Biotechnology, Toxicology or a related discipline.
• Solid and up-to-date knowledge of European cosmetic regulations.
• Previous experience in Cosmetic Regulatory Affairs (+ 5 years).
• Experience managing regulatory projects, coordinating cross-functional teams and stakeholders, working with external consultants and specialised technical providers.
• Knowledge of cosmetic safety assessment and toxicological documentation.
• Languages: Native or professional command of Italian and English (interview will be conducted in english). Spanish would be considered an advantage.

Nice to have:

• Master's degree or postgraduate qualification in Regulatory Affairs, Toxicology, Cosmetic Safety or a related field.
• Knowledge of non-European cosmetic regulations.

What they offer:

• Opportunity to join an international and growing company within the cosmetics sector.
• Flexible starting time .
• Monday-to-Friday schedule.
• On-site working model (no hybrid or smart working option)