Regulatory Intelligence Manager

1 giorno fa

Roma, Lazio, Italia Syneos Health A tempo pieno
Job Summary

The Regulatory Intelligence Department at Syneos Health plays a crucial role in shaping the company's regulatory strategy. As a key member of this team, the Manager, Regulatory Intelligence will be responsible for ensuring the accuracy and currency of the Syneos Health Regulatory Intelligence System. This involves regular surveillance and interaction with subject matter experts to gather and maintain clinical regulatory intelligence.

Key Responsibilities
  • Regulatory Intelligence Data Management: Ensure that clinical regulatory intelligence is collected and maintained in the Syneos Health Regulatory Intelligence System (RIS). This includes ensuring that country-specific regulatory requirements are current and accurate and available for services offered by Syneos Health in countries where the organization operates or intends to operate.
  • Regulatory Intelligence Research: Conduct searches within commercial Regulatory Intelligence databases to identify regulations and guidelines relevant for clinical regulatory intelligence.
  • Regulatory Intelligence Analysis: Analyze information across multiple sources and manage substantial amounts of details to support routine surveillance activities.
  • Regulatory Intelligence Communication: Interact with external and internal experts to collect country and region-specific regulatory intelligence, and work closely with Country SMEs to contribute to the overall understanding of the local regulatory landscape.
  • Regulatory Intelligence Documentation: Document the interpretation of regulatory intelligence in a standardized format within the Regulatory Intelligence System in line with implemented procedures and business needs.
  • Regulatory Intelligence Advisory: Advise, consult, and make final recommendations to all aspects of clinical regulatory intelligence.
  • Regulatory Intelligence Training: Provide regulatory and technical training within the department and/or other departments/stakeholders, as required.
Qualifications
  • Education: BS degree or equivalent demonstrated experience in a relevant field.
  • Clinical Research Experience: Clinical research experience required, including significant regulatory intelligence experience or regulatory affairs or regulatory operations, preferably from a clinical research organization.
  • Regulatory Knowledge: Good knowledge of country-specific and regional regulations.
  • Research Skills: Strong research skills required to support routine surveillance activities.
  • Communication Skills: Excellent interpersonal and communication skills.
  • Language Skills: Fluency in speaking, writing, and reading English.

  • Regulatory Compliance Manager

    1 settimana fa

    Roma, Lazio, Italia Page Personnel A tempo pieno

    About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Page Personnel. As a key member of our team, you will be responsible for managing and preparing regulatory dossiers for submissions of human drug substances to various regulatory authorities.Key ResponsibilitiesManage and prepare regulatory dossiers (CTD) for...

  • Regulatory Affairs Specialist

    6 giorni fa

    Roma, Lazio, Italia Meditrial Europe Ltd. A tempo pieno

    Job DescriptionMeditrial Europe Ltd. is a leading clinical research organization dedicated to delivering unparalleled outcomes for innovators in the life science industry. As a Regulatory Affairs Manager, you will play a crucial role in ensuring compliance with regulatory requirements for products requiring governmental approval.Key Responsibilities:Manage...

  • Regulatory Affairs Specialist

    7 giorni fa

    Roma, Lazio, Italia Meditrial Europe Ltd. A tempo pieno

    Job DescriptionMeditrial Europe Ltd. is a leading clinical research organization dedicated to delivering unparalleled outcomes for innovators in the life science industry. As a Regulatory Affairs Manager, you will play a crucial role in ensuring compliance with regulatory requirements for products requiring governmental approval.Key Responsibilities:Manage...

  • Regulatory Affairs Specialist

    1 giorno fa

    Roma, Lazio, Italia Abbott A tempo pieno

    Job Summary: Support the development of regulatory strategies for the registration and reimbursement of new products, ensuring alignment with business objectives and regulatory requirements. Maintain in-line products and monitor new regulations to support business growth. Assess the impact of upcoming regulations on products for external engagement through...

  • Global Regulatory Affairs Specialist

    1 settimana fa

    Roma, Lazio, Italia Elanco A tempo pieno

    Job Summary:This role contributes to the regional registration activities for new and existing products by planning, coordinating, and delivering registration documentation to the regulatory agencies for assigned portfolio of products registered in two or more EEA countries (or the UK).Key Responsibilities:Support submission preparation in execution of...

  • Project Manager Oracle Business Intelligence

    1 settimana fa

    Roma, Lazio, Italia Sinergidea srl A tempo pieno

    Job DescriptionSinergidea srl è un'azienda italiana specializzata nel settore IT/ICT, con competenza ed esperienza acquisite grazie a collaborazioni instaurate con realtà attive in diversi settori, come Finanza, Industria, Automotive, Utilities, Energia. Ci distinguiamo sul mercato per i nostri servizi di consulenza e per le nostre soluzioni IT in area...

  • Project Manager Oracle Business Intelligence

    6 giorni fa

    Roma, Lazio, Italia Sinergidea srl A tempo pieno

    Job DescriptionSinergidea srl è un'azienda italiana specializzata nel settore IT/ICT, con competenza ed esperienza acquisite grazie a collaborazioni instaurate con realtà attive in diversi settori, come Banking, Finance, Industry, Automotive, Utilities, Energy. Ci distinguiamo sul mercato per i nostri servizi di consulenza e per le nostre soluzioni IT in...

  • Project Manager Oracle Business Intelligence

    6 giorni fa

    Roma, Lazio, Italia Sinergidea srl A tempo pieno

    Sinergidea srl è un'azienda italiana specializzata nel settore IT/ICT, con competenza ed esperienza acquisite grazie a collaborazioni instaurate con realtà attive in diversi settori, come Banking, Finance, Industry, Automotive, Utilities, Energy. Ci distinguiamo sul mercato per i nostri servizi di consulenza e per le nostre soluzioni IT in area ICT....

  • Project Manager Oracle Business Intelligence

    2 settimane fa

    Roma, Lazio, Italia Sinergidea srl A tempo pieno

    Job DescriptionSinergidea srl è un'azienda italiana specializzata nel settore IT/ICT, con competenza ed esperienza acquisite grazie a collaborazioni instaurate con realtà attive in diversi settori, come Banking, Finance, Industry, Automotive, Utilities, Energy. Ci distinguiamo sul mercato per i nostri servizi di consulenza e per le nostre soluzioni IT in...

  • Project Manager Oracle Business Intelligence

    2 settimane fa

    Roma, Lazio, Italia Sinergidea srl A tempo pieno

    Sinergidea srl è un'azienda italiana specializzata nel settore IT/ICT, con competenza ed esperienza acquisite grazie a collaborazioni instaurate con realtà attive in diversi settori, come Banking, Finance, Industry, Automotive, Utilities, Energy. Ci distinguiamo sul mercato per i nostri servizi di consulenza e per le nostre soluzioni IT in area ICT....

  • Due Diligence and Regulatory Compliance Manager

    7 giorni fa

    Roma, Lazio, Italia Ramboll A tempo pieno

    About the RoleRamboll is seeking a highly motivated and experienced professional to lead projects and tasks primarily in due diligence, regulatory compliance, and permitting.Key ResponsibilitiesProvide project strategy, oversight, and direction for due diligence, regulatory compliance, environmental permitting, and development/decommissioning projects.Assess...

  • Clinical Operations Manager Lead

    6 giorni fa

    Roma, Lazio, Italia Merck Sharp & Dohme (Msd) A tempo pieno

    Job SummaryMerck Sharp & Dohme (Msd) is seeking a highly skilled Clinical Operations Manager Lead to join our team. This role is accountable for the execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country regulations, our company policies and procedures, and with quality standards, both internally and...

  • Clinical Operations Manager Lead

    7 giorni fa

    Roma, Lazio, Italia Merck Sharp & Dohme (Msd) A tempo pieno

    Job SummaryMerck Sharp & Dohme (Msd) is seeking a highly skilled Clinical Operations Manager Lead to join our team. This role is accountable for the execution and oversight of local operational clinical trial activities in compliance with ICH/GCP and country regulations, our company policies and procedures, and with quality standards, both internally and...

  • Engineering Project Manager

    4 settimane fa

    Roma, Lazio, Italia Michael Page A tempo pieno

    Company Overview: This organization specializes in the production of secure communication systems, focusing on advanced technologies such as radios and satellite systems. Role Summary: The Project Engineering Manager will oversee the planning, execution, and delivery of engineering projects within the defense, cybersecurity, public safety, and intelligence...

  • Clinical Quality Assurance Manager

    1 giorno fa

    Roma, Lazio, Italia Proclinical Group A tempo pieno

    Job DescriptionProclinical Group is seeking a dedicated Clinical Quality Assurance Manager to join our team. This role is crucial in ensuring that clinical trials and studies are conducted to the highest quality standards, in compliance with international standards, legislation, protocols, and company processes.Key Responsibilities:Quality Management System...

  • Manager di Progetto per Soluzioni Oracle

    2 settimane fa

    Roma, Lazio, Italia Sinergidea srl A tempo pieno

    Descrizione del LavoroSinergidea è un'azienda italiana leader nel settore IT/ICT, con una solida esperienza maturata attraverso collaborazioni con aziende operanti in vari ambiti, tra cui Finanza, Industria, Automotive, Utilities ed Energia. Ci distinguiamo per l'eccellenza dei nostri servizi di consulenza e per le innovative soluzioni IT che offriamo nel...

  • Financial Operations Manager

    1 settimana fa

    Roma, Lazio, Italia Hilton Hotels Corporation A tempo pieno

    Job SummaryHilton Hotels Corporation is seeking a highly skilled and experienced Financial Operations Manager to join our team. As an Assistant Finance Director, you will play a critical role in supporting the Finance Manager in driving financial performance, ensuring timely and accurate financial reporting, and coordinating month-end closing activities.Key...

  • Quality Assurance Manager

    6 giorni fa

    Roma, Lazio, Italia ADECCO ITALIA A tempo pieno

    Job DescriptionAdecco Italia is seeking a highly skilled Quality Assurance Manager to join our team in the Railway Sector. As a Quality Assurance Manager, you will be responsible for developing and implementing a robust quality assurance program for railway operations and maintenance.Key Responsibilities:Quality Assurance Program Management: Develop,...

  • Quality Assurance Manager

    1 settimana fa

    Roma, Lazio, Italia ADECCO ITALIA A tempo pieno

    Job DescriptionAdecco Italia is seeking a highly skilled Quality Assurance Manager to join our team in the Railway Sector. As a Quality Assurance Manager, you will be responsible for developing and implementing a robust quality assurance program for railway operations and maintenance.Key Responsibilities:Quality Assurance Program Management: Develop,...

  • R&D Analytical Manager

    1 settimana fa

    Roma, Lazio, Italia EUSA Pharma A tempo pieno

    About the RoleEUSA Pharma is seeking an experienced R&D Analytical Manager to lead our Analytical team in the development and validation of analytical methods for various stages of drug development.Key ResponsibilitiesDevelop and Implement Analytical Strategies: Define the analytical strategy for new and ongoing projects to ensure all project work is...