REGULATORY AFFAIRS MANAGER
hace 5 días
MFC- REGULATORY AFFAIRS MANAGER MADRID Overall responsibilities To provide regulatory advice and support to the organisation on the content of existing marketing authorisations and for products in development phase. To provide general regulatory advice and support to other departments. Review and approval of promotional and non-promotional material to comply with local regulation, self-regulations and internal policies and procedures. To advice the marketing teams on the promotional activities. Support pharmacovigilance department on safety relevant matters in line with national requirements. To support the Head of RA with developing and meeting the longer-term goals for the department. Main Accountabilities Obtain marketing authorizations for new pharmaceutical products, working closely with area headquarters. Maintain marketing authorizations as required. Review of promotional and non-promotional materials and activities in accordance with legislation, local procedures and codes of practice. Regulatory advice and support to Brand Team on promotional materials content and activities. Keep updated in current regulations in promotion of medicines and in Spanish Code of Practice for the Pharmaceutical Industry. Liaise and attend meetings with other company functions to provide regulatory advice for new and existing products; participation in affiliate Brand Teams regarding regulatory strategies and proposed label changes, to provide regulatory advice for new and existing products. Provide regulatory support for the Brand Teams commercial divisions in all areas pertaining to product life-cycle management and new product development. Liaise with European Regulatory Affairs and Corporate groups on regulatory matters. Liaise with national regulatory authorities as required. Maintain awareness of current and new legislation/guidance and ensure that work is in compliance with the statutory requirements. Comply with the Company’s policies and procedures to ensure consistency of the current local prescribing information with the CCDS in order to: Ensure alignment within the organization. Meet the expectations of regulatory agencies. Implement approved label through defined artwork process. Write and update local procedures in compliance with the local regulation and internal policies and procedures, if applicable. Ensure compliance with all relevant statutory requirements and all relevant internal procedures. Represent affiliate regulatory position at defined initiatives or projects from global or area. Reviews and is updated in the industry environment (e.g. regulatory, legal, EFPIA and local codes) and provides regulatory position, perspective and expertise related to advertising and promotion to business partners. Support audits and inspections. Keeps and maintains regulatory operation processes and systems to support regulatory submissions and approvals in the most efficient. Keeps and manages product registration databases to ensure information transmission timely and accurately. Qualifications Degree in Pharmacy, Life Sciences or similar. 10 years of experience in Regulatory Affairs. Strong knowledge of regulations, and special focus on expertise on regulation of promotion and the Farmaindustria Code of Practice. Project Management and Strategic Communication. The ability to thrive in a changing environment and to re-prioritise workload to meet business needs. Strong negotiation skills to build consensus. Fluent English language skills. #J-18808-Ljbffr
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Regulatory Affairs Manager
hace 2 semanas
Madrid, España Cpl Life Sciences A tiempo completoob Title:European Regulatory Affairs Manager Location:Madrid, Spain, Hybrid Regulatory Affairs Manager opportunity working for an established pharmaceutical company that specialises in generic, OTC, and prescription medicines. The business is increasingly growing and is looking for a personable and detail-oriented professional to join the small team and lead...
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Madrid, España Cpl Life Sciences A tiempo completoob Title: European Regulatory Affairs Manager Usted podría ser el solicitante perfecto para este trabajo. Lea toda la información asociada y asegúrese de presentar su candidatura. Location: Madrid, Spain, Hybrid Remuneration: Competitive salary and package Regulatory Affairs Manager opportunity working for an established pharmaceutical company that...
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Madrid, España Cpl Life Sciences A tiempo completoob Title: European Regulatory Affairs Manager ¿Es usted el solicitante adecuado para esta oportunidad? Descúbralo leyendo el resumen del puesto a continuación. Location: Madrid, Spain, Hybrid Remuneration: Competitive salary and package Regulatory Affairs Manager opportunity working for an established pharmaceutical company that specialises in generic,...
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Madrid, España Cpl Life Sciences A tiempo completoob Title: European Regulatory Affairs Manager Location: Madrid, Spain, Hybrid Remuneration: Competitive salary and package Regulatory Affairs Manager opportunity working for an established pharmaceutical company that specialises in generic, OTC, and prescription medicines. The business is increasingly growing and is looking for a personable and...
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Regulatory Affairs Manager
hace 2 semanas
Madrid, España Cpl Life Sciences A tiempo completoob Title: European Regulatory Affairs Manager Location: Madrid, Spain, Hybrid Remuneration: Competitive salary and package Regulatory Affairs Manager opportunity working for an established pharmaceutical company that specialises in generic, OTC, and prescription medicines. The business is increasingly growing and is looking for a personable and...
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Regulatory Affairs Manager
hace 1 semana
Madrid, España Cpl Life Sciences A tiempo completoob Title: European Regulatory Affairs Manager Location: Madrid, Spain, Hybrid Remuneration: Competitive salary and package Regulatory Affairs Manager opportunity working for an established pharmaceutical company that specialises in generic, OTC, and prescription medicines. The business is increasingly growing and is looking for a personable and...
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Regulatory Affairs Manager
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Madrid, España Cpl Life Sciences A tiempo completoob Title:European Regulatory Affairs Manager Location:Madrid, Spain, Hybrid Remuneration:Competitive salary and packageRegulatory Affairs Manager opportunity working for an established pharmaceutical company that specialises in generic, OTC, and prescription medicines. The business is increasingly growing and is looking for a personable and detail-oriented...
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Madrid, España Cpl Life Sciences A tiempo completoDirect message the job poster from Cpl Life SciencesManaging Consultant - Regulatory Affairs & Quality @ Cpl Life Sciencesob Title: European Regulatory Affairs ManagerLocation: Madrid, Spain, HybridRemuneration: Competitive salary and packageRegulatory Affairs Manager opportunity working for an established pharmaceutical company that specialises in generic,...
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Madrid, España Cpl Life Sciences A tiempo completoDirect message the job poster from Cpl Life SciencesPara una comprensión completa de esta oportunidad y de lo que se requerirá para ser un candidato exitoso, siga leyendo.Managing Consultant - Regulatory Affairs & Quality @ Cpl Life Sciencesob Title:European Regulatory Affairs ManagerLocation:Madrid, Spain, HybridRemuneration:Competitive salary and...
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Regulatory Affairs Manager
hace 2 semanas
Madrid, España Cpl Life Sciences A tiempo completoob Title: European Regulatory Affairs ManagerLocation: Madrid, Spain, HybridRegulatory Affairs Manager opportunity working for an established pharmaceutical company that specialises in generic, OTC, and prescription medicines. The business is increasingly growing and is looking for a personable and detail-oriented professional to join the small team and lead...
