Regulatory Affairs Specialist
hace 2 días
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.We believe that diversity adds value to our business, our teams and our culture. We are committed to equal employment opportunities that foster an inclusive environment.We are looking for a Nucleic Acid Testing (NAT) Regulatory Affairs Specialist to join Diagnostic Regulatory Affairs department.The RRAA Specialist will be responsible of the preparation of technical documentation, submission and following up of product registration and/or renewal, variations dossiers, as well as other regulatory documentation.What your responsibilities will bePrepare and send the registration and/or renewal and/or changes/variations dossiers of the relevant products.Prepare technical documentation based on the R&D inputs.Coordinate the preparation of the documents needed for regulatory submissions with R&D, manufacturing and QA departments.Define the regulatory requirements for the products.Prepare and send official responses to any Health Authority questions.Review and assess regulatory impact for product or manufacturing changes.Adapt licenses to current regulations.Manage/coordinate the delivery of product samples or labels related with product registration/renewal/change processes.Revise, approve and/or coordinate packaging material.Write and Manage SOPs.Review technical documents to ensure coherence and compliance with regulatory requirements.Who you areTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions).You have a Bachelor's Degree in Health Sciences.You have been working in RRAA within the pharmaceutical industry.You have Advanced level of Spanish and English (C1) and MS Office.You have analytical skills, attention to detail and ability to summarize and evaluate.What we offerIt is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment. Information about Grifols is available at www.grifols.com. If you are interested in joining our company and you have what it takes for such an exciting position, then don’t hesitate to apply We look forward to receiving your application We believe in diverse talent and want to remove any barriers that may hinder your participation. If you require any adjustments in our selection process, please do not hesitate to inform us when applying. We are here to help.Grifols is an equal opportunity employer.Flexible scheduleMonday-Thursday 7-10 to 16-19h and Friday 8-15h (with the same flexible start time).Benefits packageContract of EmploymentPermanent position #J-18808-Ljbffr
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NAT Regulatory Affairs Specialist
hace 1 día
Sant Cugat del Vallès, España Grifols, S.A A tiempo completoA global healthcare company is seeking a Nucleic Acid Testing (NAT) Regulatory Affairs Specialist to join their Diagnostic Regulatory Affairs department. The candidate will prepare technical documentation, manage product registrations, and ensure compliance with regulations. Applicants should possess a Bachelor's in Health Sciences, experience in Regulatory...
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NAT Regulatory Affairs Specialist
hace 2 semanas
Sant Cugat, España Grifols, S.A A tiempo completoA global healthcare company is seeking a Nucleic Acid Testing (NAT) Regulatory Affairs Specialist to join their Diagnostic Regulatory Affairs department. The candidate will prepare technical documentation, manage product registrations, and ensure compliance with regulations. Applicants should possess a Bachelor's in Health Sciences, experience in Regulatory...
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Sant Cugat del Vallès, España Grifols A tiempo completoA global healthcare company is looking for a Regulatory Affairs Specialist in Sant Cugat del Vallès. The role includes managing regulatory submissions, ensuring compliance with international regulations, and working in a hybrid model. Candidates should have a Bachelor's degree in a relevant field and 2-5 years of experience in regulatory documentation....
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sant cugat del vallès, España Grifols A tiempo completoA global healthcare company is looking for a Regulatory Affairs Specialist in Sant Cugat del Vallès. The role includes managing regulatory submissions, ensuring compliance with international regulations, and working in a hybrid model. Candidates should have a Bachelor's degree in a relevant field and 2-5 years of experience in regulatory documentation....
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Regulatory Affairs Specialist
hace 4 días
sant cugat del vallès, España Grifols, S.A A tiempo completoWould you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and...
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Regulatory Affairs Specialist
hace 4 días
sant cugat del vallès, España Grifols A tiempo completoWould you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and...
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sant cugat del vallès, España Grifols A tiempo completoA global healthcare company is seeking a Nucleic Acid Testing Regulatory Affairs Specialist in Sant Cugat del Vallès. The role involves preparing regulatory documents, coordinating submissions, and defining regulatory requirements. Candidates should have a Bachelor's in Health Sciences, experience in pharmaceutical RRAA, and advanced skills in Spanish and...
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Regulatory Affairs Specialist
hace 2 semanas
Sant Cugat del Vallès, España Grifols A tiempo completoWould you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and...
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Regulatory Affairs Specialist – French Native
hace 2 días
sant cugat sesgarrigues, España Uriach A tiempo completoA leading pharmaceutical company in Spain is seeking an Entry-Level Regulatory Affairs Specialist who is a native French speaker. In this role, you will support new projects, ensure compliance with regulations, and manage communication with regulatory bodies. Ideal candidates should be passionate about regulatory affairs and willing to collaborate with...
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Sant Cugat, España Grifols, S.A A tiempo completoA global healthcare company in Sant Cugat del Vallès seeks a Regulatory Affairs Specialist Lab Automation to enhance regulatory compliance. This hybrid position requires a Bachelor's degree in a Life Sciences field and 2-5 years of regulatory experience, specifically with IVDR and FDA regulations. The role involves maintaining interfaces with regulatory...
