Guardar Regressar à pesquisa Descrição Resumo Ofertas Semelhantes Added 21/10/2026Collaborative and multicultural working environment.Competitive compensation and benefits package.Sobre o nosso clienteOur client is a leading international pharmaceutical organization with a strong global presence and a diverse portfolio of products serving patients worldwide.DescriçãoPublish and manage regulatory submissions in eCTD and non-eCTD formats for global markets;Perform technical quality control and validation of electronic submissions to ensure compliance with Health Authority requirements;Coordinate submission schedules and ensure timely delivery against critical regulatory milestones;Act as the subject matter expert for publishing activities, providing guidance to Regulatory Affairs and cross-functional stakeholders;Troubleshoot publishing and validation issues, ensuring successful submission delivery;Support electronic transmission and archival of regulatory dossiers;Contribute to process optimisation, system enhancements, and publishing best practices;Maintain current knowledge of evolving global eCTD requirements, standards, and technologies;Support regulatory projects and system implementation initiatives;Mentor junior colleagues and contribute to knowledge sharing within the Regulatory Operations function.Perfil idealA successful 'Senior Regulatory Operations Specialist - Electronic Submissions' should have:Degree in Life Sciences, Pharmacy, Chemistry, Biotechnology, or a related discipline;Minimum of 5 years of experience in Regulatory Operations, Electronic Submissions, or Regulatory Publishing within the pharmaceutical industry;Strong practical experience with eCTD publishing and submission processes;Experience with publishing software, ideally Lorenz docuBridge;Familiarity with document management platforms such as Veeva Vault and/or Documentum D2;Strong understanding of global regulatory submission requirements and electronic dossier formats;Proven ability to manage multiple projects and deadlines simultaneously;Excellent problem-solving and troubleshooting capabilities;Strong attention to detail and organizational skills;Effective communication and stakeholder management skills;Experience working within global, cross-functional environments;Fluency in English.VantagensOpportunity to join a highly regarded global pharmaceutical organization.Collaborative and multicultural working environment.Apply to discuss the Senior Regulatory Operations Specialist - Electronic Submissions role.Pesquise mais OfertasPedro JustoQuote job refJN-102026-7131105Resumo da FunçãoSetorHealthcare & Life SciencesSubsetorAssuntos RegulamentaresAdicionar indústriaHealthcare / PharmaceuticalLocalizaçãoLisbonTipo de contratoIndefinidoNome do ConsultorPedro JustoReferência da OfertaJN-102026-7131105
