International Regulatory Affairs Specialist
2 settimane fa
Lo.Li. Pharma International, a leading company in the nutraceutical sector with a strong international presence, is looking for an International Regulatory Affairs Specialist to cover a maternity leave.General DescriptionReporting to the Quality & Regulatory Manager, the selected candidate will work within the Regulatory Affairs department on assigned projects, ensuring compliance with regulatory requirements in the countries where our products are marketed. The role involves close collaboration with internal departments and customers to prepare and manage regulatory documentation for product registration and market access.Main ResponsibilitiesManage the international registration of medical devices and food supplements for assigned clients, setting timelines and following up until completion.Collaborate with internal departments and customers to collect, develop, and prepare data and documentation for submission to regulatory authorities.Conduct research and liaise with agencies and clients to determine product classification in various markets.Prepare, archive, and maintain all regulatory documentation up to date.Review regulatory information in customer artwork and support the preparation of medical device labeling in compliance with EU regulations.Monitor and report compliance issues, regulatory process delays, and critical updates to the Quality & Regulatory Manager.Prepare monthly reports on the progress of regulatory activities and product registrations.RequirementsDegree in scientific disciplines.Excellent command of written and spoken English.Minimum 1 years of experience in Regulatory Affairs.Ability to work effectively in a fast-paced environment.Strong organizational, communication, and interpersonal skills.Location: RomeContract type: Fixed-term contract (maternity cover)What We OfferA dynamic and international work environment.Opportunities for professional growth and continuous training.A cohesive and quality-driven team.If you are motivated, detail-oriented, and passionate about regulatory affairs, send us your applicationLearn more about our company:
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