Requirements: English
Company: Chaberton Professionals
Region: Monza , Lombardy
Job Opportunity: Regulatory Affairs SpecialistChaberton Professionals, a division of Chaberton Partners dedicated to the search and selection of Middle Management profiles, is currently seeking a Regulatory Affairs Specialist for a leading company operating in the pharmaceutical sector (active pharmaceutical ingredients production).ResponsibilitiesPreparation, updating, and submission of DMFs to national, European, and extra-European regulatory agencies.Maintaining registered DMFs in AIFA up-to-date according to current regulations.Preparing regulatory documentation in response to deficiency letters from authorities or clients.Preparing and submitting variations to registered dossiers in accordance with current rules and client agreements.Supporting Quality Assurance in regulatory change evaluations.Collaborating with R&D regarding product development data and regulatory assessment of information provided for deficiency letters, new projects, or updates.Working with the Quality Control Laboratory to manage analytical data and evaluate regulatory documentation.Collaborating with Production regarding active raw materials, intermediates, and packaging materials, evaluating regulatory information provided.Coordinating with Sales on dossier submission timelines related to client applications.Providing technical and administrative support to clients, agents, and authorities.Preparing documentation for maintaining licenses and registrations of DMFs and client marketing authorizations with national, European, and international agencies.Sending notifications to clients regarding DMF and CEP updates as per internal procedures.Maintaining the regulatory archive following internal procedures.Periodically reviewing scientific publications, pharmacopoeias, and reference guidelines for updates.RequirementsDegree in Chemistry, Chemical Technology, or related fields.2-3 years of experience in Regulatory Affairs within API manufacturing companies or pharmaceutical groups.Ability to multitask and manage multiple projects simultaneously.Motivation and ability to communicate with clients worldwide for technical and regulatory support.Dynamic, proactive, and team-oriented attitude.Excellent command of the English language.LocationPavia#J-18808-Ljbffr