Regulatory Coordinator

3 settimane fa

Bardi, Italia Michael Page A tempo pieno

OverviewThe Regulatory Coordinator leads the operational regulatory activities, ensuring full compliance with local and international requirements.They manage a team through functional reporting lines, support project execution, and act as the main technical and organizational reference point.Our client is an Italian company operating in the national ingredients sector for the cosmetics, food, nutraceutical, and pharmaceutical industries.The company provides not only raw materials but also technical expertise, marketing services, and application laboratories for the development of formulations and prototypes.ResponsibilitiesLead and supervise the regulatory team, assigning tasks and monitoring deadlines, while actively participating in regulatory activities.Ensure compliance of cosmetic, food, and nutraceutical products across EU and non-EU markets.Prepare, review, and submit regulatory documentation (dossiers, notifications, registrations, labels, claims).Be updated on national and international regulations and liaise with authorities and external partners.Collaborate with R&D, Production, Marketing, Sales, and QA to support new product development and launches.Provide guidance to the team, monitor KPIs, and contribute to process improvements for efficiency and compliance.QualificationsDegree in Pharmacy, Chemistry, Biology, Food Science & Technology, or related fields.5+ years in regulatory roles, including 2+ years leading a team.Masters or specialized Regulatory Affairs courses (preferred).Deep knowledge of EMA, AIFA, FDA, EFSA guidelines; EU regulations (cosmetics *********, food ******** & *********), GMP/GDP, REACH, CLP.Dossier management and regulatory database expertise.Fluent in English, written and spoken.Details about the clientOur client is an Italian company operating in the national ingredients sector for the cosmetics, food, nutraceutical, and pharmaceutical industries.The company provides not only raw materials but also technical expertise, marketing services, and application laboratories for the development of formulations and prototypes.Profilo del CandidatoDegree in Pharmacy, Chemistry, Biology, Food Science & Technology, or related fields.5+ years in regulatory roles, including 2+ years leading a team.Masters or specialized Regulatory Affairs courses (preferred).Deep knowledge of EMA, AIFA, FDA, EFSA guidelines; EU regulations (cosmetics *********, food ******** & *********), GMP/GDP, REACH, CLP.Dossier management and regulatory database expertise.Fluent in English, written and spoken.Offerta di lavoroOttima opportunità di carriera.Desired Skills and ExperienceRegulatory AffairsCosmetic Regulation (EU *********)Food & Nutraceutical Regulation (EU ********, *********)Pharmaceutical ComplianceGMP/GDPREACH & CLPFDA / EMA / EFSA GuidelinesDossier Preparation & SubmissionRegulatory DocumentationLabeling & Claims ComplianceRegulatory DatabasesDocument Management Systems#J-*****-Ljbffr

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