Senior Regulatory Affairs Officer
hace 1 semana
QbD Groupteam offers knowledge & tailored (software) solutions in development, clinical, regulatory & compliance, production and distribution for companies active in Pharma, ATMP and Medical Devices/IVD. We are always looking for the next QbD'er in Regulatory Affairs. What do we expect from you as a Senior Regulatory Affairs Officer? You have knowledge of general pharmaceutical legislation and regulations, including GMP. Good knowledge of Spanish legal regulations on promotional and non-promotional materials is a must You have expertise in ICH guidelines and registration dossier, CTD format. You have developed Project Management roles. You have expertise in lifecycle management. You have expertise in price & reimbursement. You have expertise in regulatory submissions. And if you have expertise in ISO IDMP... is a plus Who are we looking for? You have a Master degree in Pharma Industry or Regulatory Affairs Management. Minimum of 4 years' experience in the field. You are both client and results oriented. You have good analytical skills, attention to detail and ability to manage multiple tasks and priorities at the same time. A true QbD'er can be recognized by the following qualities:
Resilient: Your strong and positive attitude helps you overcome any challenge. Hungry for knowledge: You are always open to learning. No non-sense mentality: you can be straightforward in a respectful way. Innovative: You are constantly looking for new and better solutions. (Not too) serious: your job is serious, but you don't take yourself too seriously. What's in it for you? QbD Group offers you an attractive and competitive salary package, that will be tailored to individual needs, considering legal requirements and local laws and regulations. Join us to build a sustainable career, where job security is ensured, and lasting, meaningful connections are formed. As we're a knowledge-based company, you're guaranteed to embark on a continuous journey of learning and development. Be part of our global success story. As an award-winning company we value everyone's contribution and celebrate achievements together. Our promise to you:
As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences. Moreover, we aim to create a joyful community where you dare to be and can be yourself. Because the best way to grow is by growing together as unique individuals. In short … We stand for? JPEG: Joy in Partnership, going for the Extra mile to Get things done Interested? Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family
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Senior Regulatory Affairs Officer
hace 1 semana
Pozuelo de Alarcón, España Trium Clinical Consulting Nv A tiempo completoQbD Groupteam offers knowledge & tailored (software) solutions in development, clinical, regulatory & compliance, production and distribution for companies active in Pharma, ATMP and Medical Devices/IVD.We are always looking for the next QbD'er in Regulatory Affairs.What do we expect from you as a Senior Regulatory Affairs Officer?You have knowledge of...
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Senior Regulatory Affairs Officer
hace 17 horas
Pozuelo de Alarcón, España TRIUM Clinical Consulting NV A tiempo completoQbD Groupteam offers knowledge & tailored (software) solutions in development, clinical, regulatory & compliance, production and distribution for companies active in Pharma, ATMP and Medical Devices/IVD. We are always looking for the next QbD’er in Regulatory Affairs.What do we expect from you as a Senior Regulatory Affairs Officer? You have knowledge of...
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Fdf Regulatory Affairs Officer
hace 3 meses
08130 Santa Perpètua de Mogoda, Barcelona provincia, España GENUINE A tiempo completo**FDF REGULATORY AFFAIRS OFFICER** Nuestro cliente es una compañía farmacéutica española cuyo negocio está centrado en I+D, licencia, fabricación y suministro de productos farmacéuticos. Cuenta con un amplio conocimiento y experiência en ofrecer productos y soluciones de calidad en el ecosistema de la salud. Sus valores abanderan un alto compromiso...
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Regulatory Affairs Specialist
hace 1 mes
Cornellà de Llobregat, Barcelona, España ES16 Alcon Healthcare S.A. Company A tiempo completoAt ES16 Alcon Healthcare S.A. Company, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you'll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact...
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Regulatory Affairs Manager
hace 2 meses
Cornellà de Llobregat, España ES16 Alcon Healthcare S.A. Company A tiempo completoAt Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our...
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Regulatory Affairs Specialist
hace 4 semanas
Cornellà de Llobregat, Barcelona, España ES16 Alcon Healthcare S.A. Company A tiempo completoAt ES16 Alcon Healthcare S.A. Company, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you'll be recognized for your commitment and contributions and see your career like never before.The Regulatory Affairs Manager is responsible for...
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Regulatory Affairs Trainee
hace 3 días
San Agustín de Guadalix, Madrid provincia, España BD A tiempo completo**Job Description Summary**: As Regulatory Affairs Trainee you will learn and develop from executing and supporting the activities of the Regulatory Affairs Operations team. The scope extends across BD business units and all EMEA countries. The activities are related with regulatory responsibilities to execute regulatory processes and provide support (with...
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Regulatory Affairs Consultant
hace 1 mes
El Prat de Llobregat, Barcelona, España Clarivate A tiempo completoAbout the RoleWe are seeking a highly skilled Regulatory Affairs Consultant to join our Clinical and Regulatory Team at Clarivate. This is an exciting opportunity to work on regulatory and quality consulting projects, leveraging your expertise in regulatory affairs and quality assurance.Key ResponsibilitiesAct as a point of contact for customers throughout a...
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Cornellà de Llobregat, Barcelona, España ES16 Alcon Healthcare S.A. Company A tiempo completoAt ES16 Alcon Healthcare S.A. Company, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care.The Regulatory Affairs Specialist for Medical Devices is responsible for preparing high-quality and timely regulatory applications and notifications to...
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Regulatory Affairs Analyst
hace 6 meses
Sant Feliu de Llobregat, España Centrient Pharmaceuticals Netherlands A tiempo completoCentrient Pharmaceuticals is the leading manufacturer of beta-lactam antibiotics, and a provider of next generation statins and anti-fungals. We produce and sell intermediates, active pharmaceutical ingredients and finished dosage forms. We stand proudly at the centre of modern healthcare, as a maker of essential and life-saving medicines. With our...
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Regulatory Affairs Manager
hace 2 meses
Cornellà de Llobregat, Barcelona provincia, España Alcon A tiempo completoAt Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our...
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Consultant RA QA
hace 6 meses
El Prat de Llobregat, España Clarivate A tiempo completoWe are looking for a RAQA Consultant ( Regulatory Affairs / Quality Assurance ) to join our Clinical and Regulatory Team. This is an amazing opportunity to work on regulatory and quality consulting projects. We have a great skill set in data monitoring, content writing and consulting for multiple domains- regulatory submissions, clinical trials,...
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Deputy Local Safety Officer
hace 2 meses
28223 Pozuelo de Alarcón, Madrid provincia, España Daiichi Sankyo Europe A tiempo completoThis position primarily serves as Deputy Local Safety Officer (LSO) for our Spanish and Italian Affiliates and is accountable to ensure compliance with relevant pharmacovigilance (PV) regulatory requirements globally and locally, and ensuring the local PV systems are operating appropriately by executing operational PV tasks. Act as the Deputy of the...
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El Prat de Llobregat, Barcelona, España Clarivate A tiempo completoWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Clarivate.About the RoleThis is a permanent full-time position that offers a competitive salary of $90,000 - $110,000 per year, depending on experience. The working schedule is flexible, mostly centered on CET time zone with occasional need to accommodate late or early meetings...
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Study Start Up Associate
hace 2 semanas
28224 Pozuelo de Alarcón, Madrid provincia, España ICON Plc A tiempo completoStudy Start Up Associate II - Fluent Dutch Required ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development Study Start Up Associate / Regulatory...
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International Regulatory Affairs
hace 6 meses
Azuqueca de Henares, España Morgan Philips Executive Search A tiempo completo**Global Responsability**: Support new regulatory submissions and assisting with the lifecycle management of the existing portfolio making sure that any variations and/or renewals will be submitted in time to ensure regulatory compliance. **Specific Responsibilities**: Support and provide the necessary documentation to local affiliates and clients for...
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Regulatory Consultant
hace 3 semanas
El Prat de Llobregat, Barcelona, España Clarivate A tiempo completoWe are seeking a skilled Regulatory Consultant to join our Clinical and Regulatory Team. As a key member, you will work on regulatory consulting projects, leveraging your expertise in data monitoring, content authoring, and regulatory landscape analysis.About YouBachelor's or master's degree in pharmaceutical sciencesAt least 5 years of relevant work...
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Regulatory Solutions Consultant
hace 1 mes
El Prat de Llobregat, Barcelona, España Clarivate A tiempo completoWe are seeking a highly skilled Regulatory Solutions Consultant to join our Clinical and Regulatory Team. This is an exciting opportunity to work on regulatory consulting projects, leveraging your expertise in data monitoring, content writing, and consulting for multiple domains.About YouBachelor's or master's degree in pharmaceutical sciencesAt least 5...
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Content Manager
hace 1 semana
El Prat de Llobregat, Barcelona, España Clarivate A tiempo completoAbout the RoleWe are seeking an experienced Content Manager to join our team in Barcelona. As a key member of our Content Function, you will be responsible for managing a global team and driving the execution and performance of our content operations.About the TeamYou will be reporting to the Director, Content Editing, Regulatory and Market Access, based in...
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Medical Expert Hematology
hace 2 meses
Pozuelo de Alarcón, España Daiichi Sankyo Europe A tiempo completo.Passion for Innovation. Compassion for Patients.With over 120 years of experience and more than 17,000 employees in over 20 countries, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.In Europe, we focus on two areas: The goal of our Specialty Business is to protect...