REGULATORY AFFAIRS MANAGER
hace 1 semana
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 3 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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Regulatory Affairs Manager
hace 1 semana
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 20 horas
Madrid, Madrid, España Intelstack A tiempo completoJob Title: Contractor Local Regulatory Affairs ManagerLocation:SpainJob Type:Contract RoleDuration: 11 MonthsJob DescriptionWe are inviting applications for the role of Contractor Local Regulatory Affairs Manager for the Turkey market. The ideal candidate will have extensive experience in regulatory affairs, specifically in lifecycle management (LCM) and...
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Regulatory Affairs Manager
hace 6 días
madrid, España Hezuo Ltd A tiempo completoAs Regulatory Affairs Manager, you’ll play a pivotal role in supporting the geographical expansion of a dietary supplement ingredient business. Based in Barcelona, you’ll coordinate regulatory activities that ensure timely and compliant product registrations, authorizations, marketing & scientific communication across international markets, while...
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Regulatory Affairs Manager
hace 1 semana
Madrid, España AstraZeneca A tiempo completo**1. MISIÓN** Implantar la estrategia regulatoria local definida por el Regulatory Affairs Head y coordinar/gestionar el plan de trabajo regulatorio local en estrecha colaboración con los equipos cross-funcionales locales y con la función global, asegurando el cumplimiento de los requerimientos internos y externos aplicables. **2....
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Regulatory Affairs Manager
hace 1 semana
Madrid, España Hezuo Ltd A tiempo completoAsRegulatory Affairs Manager , you’ll play a pivotal role in supporting the geographical expansion of adietary supplement ingredient business . Based inBarcelona , you’ll coordinate regulatory activities that ensure timely and compliant product registrations, authorizations, marketing & scientific communication across international markets, while...
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Regulatory Affairs Manager
hace 3 días
Madrid, España Industria farmaceutica A tiempo completoDesde Grafton Recruitment estamos colaborando con un importante laboratorio farmacéutico en la búsqueda de un Regulatory Affairs Manager para liderar las actividades regulatorias y garantizar el cumplimiento normativo en todas las operaciones.Responsabilidades principalesGestionar y coordinar los procesos regulatorios para productos farmacéuticos,...
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Regulatory Affairs Manager
hace 1 semana
Madrid, España Industria farmaceutica A tiempo completoDesde Grafton Recruitment estamos colaborando con un importante laboratorio farmacéutico en la búsqueda de un Regulatory Affairs Manager para liderar las actividades regulatorias y garantizar el cumplimiento normativo en todas las operaciones.Responsabilidades principales- Gestionar y coordinar los procesos regulatorios para productos farmacéuticos,...
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Regulatory Affairs Manager Pharma
hace 1 semana
Madrid, España Oxford Global Resources A tiempo completoOxford Global Resources is seeking aGlobal CMC Regulatory Affairs Manager Consultant to support as external contractor on behalf of Oxford a top leading pharma companyto support headquartered in Barcelona through our consulting services division.Provide CMC regulatory insight and advice to multidisciplinary teams, as well as CMC technical functions on CMC /...
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Regulatory Affairs Officer, Spain
hace 1 semana
Majadahonda, Madrid provincia, España Linical Europe A tiempo completoLinical Co., Ltd. (‘Linical’) is a premier global CRO headquartered in Osaka, Japan, listed in the prime segment of the Tokyo Stock exchange, and dedicated to serve its clients as a true partner in development. With approximately 900 employees Linical directly covers a total of more than 20 countries in Europe, North America and Asia-Pacific including...
