Regulatory Affairs Manager Labeling + Submissions

hace 1 mes

Zaragoza, España Pharmalex A tiempo completo

**We are growing, grow with us**
Cencora PharmaLex is one of the leading service providers for the global pharmaceutical industry. We offer end-to-end regulated services and specialize in all aspects of approval and maintenance of medicinal products and medical devices. We support pharma companies throughout the entire product lifecycle, ensuring initial submissions and approvals as well as keeping compliance with pharmaceutical regulations worldwide. Our services extend way beyond market approval, providing high level strategic consultancy as well as hands-on work to extend product registrations into new markets across all regions of the world.

The success of our company grows with the excellent expertise and the high motivation of our employees.

If for you, your profession is not only a job but also a vocation and you enjoy working with people and in teams as part of a global organization, then you are very welcome to join us.

To strengthen our successful team, we are looking for a:
**Regulatory Affairs Manager Labeling + Submissions**

**Your Job**
- Participation in the preparation and revision and compilation of the informative texts for healthcare professionals and patients (SmPC, PIL, Labelling) in EU and also for non-EU markets, preferably including development of target product/labelling profiles
- Manages creation and maintenance of CCDS/CCSI/RSI, as applicable, in direct collaboration with relevant departments/expert functions responsible for CCDS section content (e.g. from medical, safety department)
- Ensures communication to internal / external stakeholders regarding new and updated CCDSs
- Escalates deviation and compliance issues to the labelling governance bodies (e.g. Safety monitoring committee, Global labelling boards) as necessary
- Experience in labelling documentation and informative texts for innovator drugs on a global (headquarter) level
- Communication and interaction within the project team, with customers, local partners and health authorities in a regional and/or an international context
- Coordination and management of project teams with internal and external staff and global partners incl. reporting and oversight activities and responsibilities
- Responsible for the planning, filing and prosecution of Regulatory Affairs projects
- Revision of approval documents including tracking of updates and respective handling of databases and document management systems
- Providing regulatory expertise to regulatory programs and projects as well as to clients
- General guidance (consultancy) of PharmaLex staff and customers regarding Regulatory Submissions & Labelling activities including also updates on new trends and/or changes in legislation
- Professional interaction with clients and Health Authorities
- Coordination of project teams with internal / external staff and Regulatory Partners on a world-wide level

**Your Profile**
- You speak fluent business English or English is your mother tongue, preferably you also have skills in another EU language
- You have successfully completed preferably a degree in pharmacy, medicine or other life sciences or a bachelor’s degree in science, engineering or mathematical domain
- You have professional experience in regulatory affairs with a profound track record in labeling activities for innovator drugs on a global level
- You bring experience in handling of marketing authorizations and their lifecycle management
- You have sound knowledge of current pharmaceutical and regulatory requirements (EU) and ideally in one ICH region
- You have an affinity for databases, labeling software tools and project management software and are used to closely monitor and adhere to timelines
- You are a team player, communicative, conscientious, accurate and responsible
- Confident with MS Excel and MS Word as well as databases and document management systems

**We offer**
- Diverse and challenging job
- Open and appreciative corporate culture
- Flexible working hours based on trust
- Possibility to work reduced number of hours
- Possibility to work from home
- Continuous development opportunities through knowledge and experience as well as training

Agencies only by prior agreement for the specific job opportunity.

  • Manager Regulatory Submission

    hace 1 mes

    Zaragoza, España Pharmalex A tiempo completo

    **We are growing, grow with us!** Want to work in a dynamic company with daily new challenges and opportunities? Then PharmaLex is your career opportunity. PharmaLex is one of the leading service providers for the global pharmaceutical industry. We offer end-to-end regulated services and specialize in all aspects of approval and maintenance of medicinal...

  • Regulatory Affairs Pharma

    hace 2 semanas

    Zaragoza, España Jr Spain A tiempo completo

    col-wideJob Description:Desde la división de Life Sciences de Hays, nos encontramos en búsqueda de un Regulatory Affairs Technician / Técnico de Asuntos Regulatorios, para una importante y reconocida Compañía que trabaja directamente para empresas del sector Pharma, Biotech & Medical Devices, ubicada en la provincia de Zaragoza.Te integrarás como...

  • Regulatory Affairs Pharma

    hace 5 días

    Zaragoza, España Jr Spain A tiempo completo

    col-wideJob Description:Desde la división de Life Sciences de Hays, nos encontramos en búsqueda de un Regulatory Affairs Technician / Técnico de Asuntos Regulatorios, para una importante y reconocida Compañía que trabaja directamente para empresas del sector Pharma, Biotech & Medical Devices, ubicada en la provincia de Zaragoza.Te integrarás como...

  • R&D Manager, Analytical Development Expert

    hace 3 semanas

    Zaragoza, España Optimaes Talent A tiempo completo

    R&D Manager, Analytical Development ExpertReporta a: Head of Pharmaceutical Affairs (France)Fecha: Abril 2024MISIÓN DEL PUESTO:Manage R&D Analytical activities (stability programs, development, technical expertise on analytical methods, APIs, ), to support development of new products and life cycle management of existing products.FUNCIONES...

  • R&D Manager, Analytical Development Expert

    hace 3 semanas

    Zaragoza, España Optimaes Talent A tiempo completo

    R&D Manager, Analytical Development Expert Reporta a: Head of Pharmaceutical Affairs (France)Fecha: Abril 2024MISIÓN DEL PUESTO:Manage R&D Analytical activities (stability programs, development, technical expertise on analytical methods, APIs, ), to support development of new products and life cycle management of existing products.FUNCIONES...

  • R&D Manager, Analytical Development Expert

    hace 3 semanas

    Zaragoza, España Optimaes Talent A tiempo completo

    R&D Manager, Analytical Development ExpertReporta a: Head of Pharmaceutical Affairs (France)Fecha: Abril 2024MISIÓN DEL PUESTO:Manage R&D Analytical activities (stability programs, development, technical expertise on analytical methods, APIs, ), to support development of new products and life cycle management of existing products.FUNCIONES...

  • Manager Quality Management

    hace 2 semanas

    Zaragoza, España Pharmalex A tiempo completo

    **We are growing, grow with us!** Are you looking for a dynamic company with daily new challenges and opportunities? Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any...

  • Adpromo Senior Manager

    hace 1 mes

    Zaragoza, España Pharmalex A tiempo completo

    **We are growing, grow with us!** Are you looking for a dynamic company with daily new challenges and opportunities? Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any...

  • Promotional Materials Manager

    hace 4 semanas

    Zaragoza, España Pharmalex A tiempo completo

    **We are growing, grow with us!** Are you looking for a dynamic company with daily new challenges and opportunities? Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any...

  • Facility Manager

    hace 1 mes

    Zaragoza, España Hitachi Vantara Corporation A tiempo completo

    Description Reporting to the Country Real Estate Manager, you will be responsible for overseeing the maintenance, operation, and optimization of the facility's infrastructure and systems. Your role is crucial in ensuring the smooth and efficient functioning of the production site while adhering to standards and safety regulations. The role is to be based...

  • Facility Manager

    hace 5 días

    Zaragoza, España Hitachi Vantara Corporation A tiempo completo

    Description Reporting to the Country Real Estate Manager, you will be responsible for overseeing the maintenance, operation, and optimization of the facility's infrastructure and systems. Your role is crucial in ensuring the smooth and efficient functioning of the production site while adhering to standards and safety regulations. The role is to be based...

  • Pharmacovigilance Manager

    hace 1 mes

    Zaragoza, España Pharmalex A tiempo completo

    **We are growing, grow with us!** Are you looking for a dynamic company with daily new challenges and opportunities? Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any...

  • Facility Manager

    hace 2 semanas

    Zaragoza, España Hitachi Abb Power Grids A tiempo completo

    Reporting to the Country Real Estate Manager, you will be responsible for overseeing the maintenance, operation, and optimization of the facility's infrastructure and systems. Your role is crucial in ensuring the smooth and efficient functioning of the production site while adhering to standards and safety regulations. The role is to be based either in our...

  • Facility Manager

    hace 5 días

    Zaragoza, España Hitachi Abb Power Grids A tiempo completo

    Reporting to the Country Real Estate Manager, you will be responsible for overseeing the maintenance, operation, and optimization of the facility's infrastructure and systems. Your role is crucial in ensuring the smooth and efficient functioning of the production site while adhering to standards and safety regulations. The role is to be based either in our...

  • Facility Manager

    hace 2 días

    Zaragoza, España Hitachi Energy A tiempo completo

    Reporting to the Country Real Estate Manager, you will be responsible for overseeing the maintenance, operation, and optimization of the facility's infrastructure and systems. Your role is crucial in ensuring the smooth and efficient functioning of the production site while adhering to standards and safety regulations. The role is to be based either in our...

  • Pharmaceutical R&d Analytics Activities Manager

    hace 5 días

    Muel, Zaragoza provincia, España optimaes A tiempo completo

    Importante empresa farmacéutica con sede en Muel (Zaragoza) desea incorporar un perfil que proceda de la parte de R&D Tecnología Farmaceútica y desarrollo de Producto GMP Farmacéutico y experto en Desarrollos Analíticos y Métodos Analíticos. Gestionaría desde la planta de Muel el equipo de R&D analytical activities pero reportaría al Head of...

  • Pharmaceutical R&d Analytics Activities Manager

    hace 6 días

    Muel, Zaragoza provincia, España optimaes A tiempo completo

    Importante empresa farmacéutica con sede en Muel (Zaragoza) desea incorporar un perfil que proceda de la parte de R&D Tecnología Farmaceútica y desarrollo de Producto GMP Farmacéutico y experto en Desarrollos Analíticos y Métodos Analíticos. Gestionaría desde la planta de Muel el equipo de R&D analytical activities pero reportaría al Head of...

  • Key Account Manager

    hace 4 días

    Zaragoza, España Biogen A tiempo completo

    The Key Account Manager’s main responsibilities are to maximise the success of sales and profits of Biogen’ biosimilar products by coordinating the input and activities of commercial and medical functions related to their territory in alignment with Biogen’s Code of Conduct, compliance and regulatory standards. **1. Main responsibilities**: - Develop...

  • Facility Manager

    hace 1 mes

    Zaragoza, España Hitachi Automotive Systems Americas, Inc. A tiempo completo

    Facilities Maintenance Engineering page is loaded Facilities Maintenance Engineering Apply locations Zaragoza, Zaragoza, Spain Trapagaran, Vizcaya, Spain time type Full time posted on Posted Today job requisition id R0044866 Location: Zaragoza, Zaragoza, SpainJob ID: R0044866Date Posted: 2024-02-28Company Name: HITACHI ENERGY SPAIN, S.A.U.Profession (Job...

  • Facility Manager

    hace 5 días

    Zaragoza, España Hitachi Automotive Systems Americas, Inc. A tiempo completo

    Facilities Maintenance Engineering page is loaded Facilities Maintenance Engineering Apply locations Zaragoza, Zaragoza, Spain Trapagaran, Vizcaya, Spain time type Full time posted on Posted Today job requisition id R0044866 Location: Zaragoza, Zaragoza, SpainJob ID: R0044866Date Posted: 2024-02-28Company Name: HITACHI ENERGY SPAIN, S.A.U.Profession (Job...