Regulatory Affairs and Labelling Manager

hace 7 días

Pamplona, Navarra, España PharmaLex A tiempo completo

Your Role

Engage in the formulation, revision, and assembly of informative materials aimed at healthcare professionals and patients (SmPC, PIL, Labelling) for both EU and non-EU markets, ideally encompassing the development of targeted product/labelling profiles. Oversee the creation and upkeep of CCDS/CCSI/RSI, collaborating directly with pertinent departments and expert functions responsible for the content of CCDS sections (e.g., from medical and safety departments). Facilitate communication with internal and external stakeholders regarding new and updated CCDSs. Report deviations and compliance concerns to the labelling governance bodies (e.g., Safety Monitoring Committee, Global Labelling Boards) as required. Possess experience in labelling documentation and informative texts for innovator pharmaceuticals at a global (headquarter) level. Ensure that regulatory affairs, development consulting, and scientific affairs initiatives are executed to high standards. Strategically plan and accelerate approval projects utilizing available internal or client-based software tools, including databases and document management systems. Provide regulatory expertise to regulatory programs and projects, as well as to clients. Offer general guidance (consultancy) to PharmaLex staff and clients regarding Regulatory Submissions & Labelling activities, including updates on emerging trends and legislative changes. Deliver seminars and presentations on behalf of PharmaLex, both internally and for external audiences. Create, revise, edit, and maintain regulatory documentation. Engage in professional interactions with clients and Health Authorities. Coordinate project teams with internal and external personnel and Regulatory Alliance Partners on a global scale. Participate in strategic regulatory discussions, including defining suitable resolution methods. Provide technical support to business development, focusing on Labelling activities and related areas at the EU level and ideally on a global scale.

Your Qualifications

Proficient in business English or a native English speaker, with additional skills in another EU language preferred. Hold a degree in pharmacy, medicine, or other life sciences, or a bachelor's degree in a scientific, engineering, or mathematical field. Have professional experience in regulatory affairs with a strong background in labelling activities for innovator drugs on a global scale. Experience in managing marketing authorizations and their lifecycle is essential. Possess a solid understanding of current pharmaceutical and regulatory requirements (EU) and ideally in one ICH region. Demonstrate an affinity for databases, labelling software tools, and project management software, with a commitment to monitoring and adhering to timelines. Be a collaborative team player, communicative, meticulous, and responsible. Proficient in MS Excel and MS Word, as well as databases and document management systems.

What We Provide

A diverse and stimulating role. An open and respectful corporate culture. Flexible working hours based on trust. Opportunities for reduced working hours . Options to work remotely. Continuous development opportunities through knowledge acquisition and training.

  • Regulatory Affairs and Labelling Manager

    hace 7 días

    Pamplona, Navarra, España PharmaLex A tiempo completo

    Your Role Engage in the formulation, revision, and assembly of informative materials intended for healthcare professionals and patients (SmPC, PIL, Labelling) within the EU and for international markets, ideally involving the development of target product/labelling profiles. Oversee the creation and upkeep of CCDS/CCSI/RSI, collaborating directly with...

  • Regulatory Affairs and Labelling Manager

    hace 4 semanas

    Pamplona, Navarra, España PharmaLex A tiempo completo

    Your Role Engage in the formulation, revision, and assembly of informative materials intended for healthcare professionals and patients (SmPC, PIL, Labelling) within the EU and for international markets, ideally involving the development of target product/labelling profiles. Oversee the creation and upkeep of CCDS/CCSI/RSI, collaborating directly with...

  • Manufacturing and Operations Manager

    hace 7 días

    Pamplona, Navarra, España Limagrain Europe A tiempo completo

    **Job Summary**We are seeking a highly experienced and skilled Manufacturing and Operations Manager to lead our operations in Spain. As a key member of the Limagrain Spanish Management Committee, you will be responsible for coordinating the operations activities in Spain, including two plants and a laboratory, from harvest reception to shipment.**Key...

  • Manufacturing and Operations Manager

    hace 7 días

    Pamplona, Navarra, España Limagrain Europe A tiempo completo

    **Job Summary**We are seeking a highly experienced and skilled Manufacturing and Operations Manager to lead our operations in Spain. As a key member of the Limagrain Spanish Management Committee, you will be responsible for coordinating the operations activities in Spain, including two plants and a laboratory, from harvest reception to shipment.**Key...

  • Warehouse and Logistics Manager

    hace 5 días

    Pamplona, Navarra, España Sungrow Europe A tiempo completo

    About the RoleWe are seeking a highly skilled and experienced Warehouse and Logistics Manager to join our team at Sungrow Europe. As a key member of our operations team, you will be responsible for managing the day-to-day activities of our warehouse and repair center, ensuring the efficient and effective flow of goods and materials.Key...

  • Warehouse and Logistics Manager

    hace 5 días

    Pamplona, Navarra, España Sungrow Europe A tiempo completo

    About the RoleWe are seeking a highly skilled and experienced Warehouse and Logistics Manager to join our team at Sungrow Europe. As a key member of our operations team, you will be responsible for managing the day-to-day activities of our warehouse and repair center, ensuring the efficient and effective flow of goods and materials.Key...

  • Warehouse and Logistics Manager

    hace 1 semana

    Pamplona, Navarra, España Sungrow Europe A tiempo completo

    About the RoleWe are seeking a highly skilled and experienced Warehouse and Logistics Manager to join our team at Sungrow Europe. As a key member of our operations team, you will be responsible for managing the day-to-day activities of our warehouse and repair center, ensuring the efficient and effective flow of goods and materials.Key...

  • Warehouse and Logistics Manager

    hace 7 días

    Pamplona, Navarra, España Sungrow Europe A tiempo completo

    About the RoleWe are seeking a highly skilled and experienced Warehouse and Logistics Manager to join our team at Sungrow Europe. As a key member of our operations team, you will be responsible for managing the day-to-day activities of our warehouse and repair center, ensuring the efficient and effective flow of goods and materials.Key...

  • Senior EU Project Manager

    hace 1 semana

    Pamplona, Navarra, España Sploro A tiempo completo

    About the RoleWe are seeking an experienced EU Project Manager to join our team at Sploro, a company dedicated to supporting entrepreneurship and innovation in Europe. As a key member of our team, you will play a crucial role in executing Horizon Europe projects and driving our company's growth.Key ResponsibilitiesManage and execute Horizon Europe projects,...

  • Senior EU Project Manager

    hace 7 días

    Pamplona, Navarra, España Sploro A tiempo completo

    About the RoleWe are seeking an experienced EU Project Manager to join our team at Sploro, a company dedicated to supporting entrepreneurship and innovation in Europe. As a key member of our team, you will play a crucial role in executing Horizon Europe projects and driving our company's growth.Key ResponsibilitiesManage and execute Horizon Europe projects,...

  • Indirects and Capex Sourcing Manager

    hace 6 días

    Pamplona, Navarra, España Nordex Group A tiempo completo

    Job SummaryWe are seeking a highly skilled Indirects and Capex Sourcing Manager to join our team at Nordex Group. As a key member of our Sourcing and Procurement department, you will be responsible for providing strategic financial guidance and supporting the achievement of departmental goals.Key ResponsibilitiesPerformance Management: Oversee the...

  • Indirects and Capex Sourcing Manager

    hace 5 días

    Pamplona, Navarra, España Nordex Group A tiempo completo

    Job SummaryWe are seeking a highly skilled Indirects and Capex Sourcing Manager to join our team at Nordex Group. As a key member of our Sourcing and Procurement department, you will be responsible for providing strategic financial guidance and supporting the achievement of departmental goals.Key ResponsibilitiesPerformance Management: Oversee the...

  • EU Project Manager

    hace 6 horas

    Pamplona, Navarra, España Sploro A tiempo completo

    About the RoleWe are seeking an experienced EU Project Manager to join our team at Sploro. As a key member of our innovation ecosystem, you will play a crucial role in executing Horizon Europe projects and driving entrepreneurship across Europe.Key ResponsibilitiesManage and execute Horizon Europe projects, ensuring timely delivery of project milestones and...

  • EU Project Manager

    hace 2 horas

    Pamplona, Navarra, España Sploro A tiempo completo

    About the RoleWe are seeking an experienced EU Project Manager to join our team at Sploro. As a key member of our innovation ecosystem, you will play a crucial role in executing Horizon Europe projects and driving entrepreneurship across Europe.Key ResponsibilitiesManage and execute Horizon Europe projects, ensuring timely delivery of project milestones and...

  • International Site Manager

    hace 8 horas

    Pamplona, Navarra, España Quality And Intelligence Press Controls Ibérica, S. L. A tiempo completo

    About the RoleWe are seeking a highly skilled and experienced International Site Manager to join our team at Quality And Intelligence Press Controls Ibérica, S. L. in Navarra. As a key member of our team, you will be responsible for the on-site installation and commissioning activities, managing the team on-site, and ensuring the delivery of high-quality...

  • International Site Manager

    hace 4 horas

    Pamplona, Navarra, España Quality And Intelligence Press Controls Ibérica, S. L. A tiempo completo

    About the RoleWe are seeking a highly skilled and experienced International Site Manager to join our team at Quality And Intelligence Press Controls Ibérica, S. L. in Navarra. As a key member of our team, you will be responsible for the on-site installation and commissioning activities, managing the team on-site, and ensuring the delivery of high-quality...

  • Production Operations Manager

    hace 6 días

    Pamplona, Navarra, España Avient A tiempo completo

    Job SummaryAs a key member of the Avient team, the Production Operations Manager will be responsible for the safe and efficient operation of all production lines assigned. This role will oversee the management of production processes, ensuring that they are running smoothly and efficiently, while also fostering a culture of safety, quality, and continuous...

  • Production Operations Manager

    hace 5 días

    Pamplona, Navarra, España Avient A tiempo completo

    Job SummaryAs a key member of the Avient team, the Production Operations Manager will be responsible for the safe and efficient operation of all production lines assigned. This role will oversee the management of production processes, ensuring that they are running smoothly and efficiently, while also fostering a culture of safety, quality, and continuous...

  • Production Operations Manager

    hace 6 días

    Pamplona, Navarra, España Avient A tiempo completo

    Job SummaryAs a key member of the Avient team, the Production Operations Manager will be responsible for the safe and efficient operation of all production lines assigned. This role will oversee the management of production processes, ensuring that they are running smoothly and efficiently, while also fostering a culture of safety, quality, and continuous...

  • Production Operations Manager

    hace 6 días

    Pamplona, Navarra, España Avient A tiempo completo

    Job SummaryAs a key member of the Avient team, the Production Operations Manager will be responsible for the safe and efficient operation of all production lines assigned. This role will oversee the management of production processes, ensuring that they are running smoothly and efficiently, while also fostering a culture of safety, quality, and continuous...