Line Manager

5 giorni fa

roma, Italia Resourcing Life Science A tempo pieno

What to ExpectLine management, training of Regulatory SpecialistTraining of the direct reports in EMEA / FDA requirementsEstablish and manage regulatory submission timelines for both new and existing products across key global marketsEngage with regulatory authorities and distribution partners to support product registrationsConduct global regulatory impact assessments for product and manufacturing changes through the document control process; prepare and submit required regulatory updates.Act as the regulatory representative on cross‑functional teams, collaborating with product development and manufacturing to integrate regulatory requirements throughout the product lifecycle.Interpret and apply international regulations, standards, and directives to ensure ongoing global complianceSupport and participate in inspections and audits conducted by global regulatory authorities.RequirementsMin 8 years in regulatory affairsMin 4 years as Regulatory Affairs ManagerExperience with EMEA / FDA regulatory requirementsIdeally line management of a teamExcellent written and verbal in EnglishAvailability to work 4 days in the officeIf you have difficulty in applying, have any questions or you cannot find what you are looking for please contact us on 0044 (0) or email #J-18808-Ljbffr

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