Empleos actuales relacionados con Regulatory Affairs Manager Labeling + Submissions - Zaragoza - Pharmalex
-
Manager Regulatory Affairs Cmc
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...
-
Fertilizer Regulatory Affairs Zaragoza
hace 2 semanas
Zaragoza, España Fertinagro Biotech International A tiempo completo**Descripción**: At **Fertinagro Biotech International,** we seek to expand our Team with an Fertilizer Regulatory Affairs Assistant (job offer or Internship offer with contract option) for a location in Zaragoza who, with their work and effort, will help us contribute to the United Nations Sustainable Development Goals 8, 12 and 16. Reporting to the...
-
Regulatory Affairs Pharma
hace 3 días
Zaragoza, España Hays A tiempo completoDesde 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 en un...
-
REGULATORY AFFAIRS ASSISTANT
hace 4 semanas
Zaragoza, España Ayanet A tiempo completo¿Quieres tener un Plan de Carrera en una empresa donde trabajar de 7 a 15, recibir formación continua en un ambiente de trabajo super agradable?Empresa puntera en el sector cosmético ubicada en Zaragoza, busca incorporar:REGULATORY AFFAIRS ASSISTANT & INTERNATIONAL PRODUCT DEVELOPMENT¿Qué te aportará esta posición?Formación y Aprendizaje: Vas a poder...
-
Senior Regulatory- Labelling
hace 5 días
Zaragoza, Zaragoza, España PharmaLex A tiempo completoOur team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals...
-
Químico
hace 2 semanas
zaragoza, España Arvensis Agro - Fertilizantes ecológicos y nutrición vegetal A tiempo completoRegulatory & Environmental Affairs | Genetista vegetal y biotecnóloga
-
Químico
hace 2 semanas
Zaragoza, España Arvensis Agro - Fertilizantes ecológicos y nutrición vegetal A tiempo completoRegulatory & Environmental Affairs | Genetista vegetal y biotecnóloga
-
RF HW Compliance Engineer, Hardware Compliance Team
hace 1 semana
zaragoza, España Amazon A tiempo completoRF HW Compliance Engineer, Hardware Compliance Team An RF Compliance Engineer ensures that wireless devices and systems meet regulatory requirements for radio frequency (RF) emissions and performance. This involves a deep understanding of RF systems, testing methodologies, and international regulations. Key Responsibilities Lead and manage product...
-
RF HW Compliance Engineer, Hardware Compliance Team
hace 1 semana
Zaragoza, España Amazon A tiempo completoRF HW Compliance Engineer, Hardware Compliance TeamObtenga más información sobre las tareas generales relacionadas con esta oportunidad a continuación, así como sobre las habilidades requeridas.An RF Compliance Engineer ensures that wireless devices and systems meet regulatory requirements for radio frequency (RF) emissions and performance. This involves...
-
Zaragoza, España Prodeval limited A tiempo completoA rapidly growing company in Zaragoza seeks a Project Manager to oversee project responsibilities, manage customer relations, and ensure regulatory compliance. Candidates should hold a Bachelor's or Master's degree in Engineering and have at least 5 years of experience in industrial projects. The role requires strong organizational skills and fluency in...
Regulatory Affairs Manager Labeling + Submissions
hace 3 semanas
**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.
