Regulatory Affairs Manager
hace 2 meses
.Regulatory Affairs Manager Location: London St Pancras Competitive salary, bonus & benefits Join our Biopharmaceuticals Business Unit as a Regulatory Affairs Manager and play a pivotal role in identifying regulatory strategies to support commercial and business objectives. This role offers the opportunity to plan and execute workload for defined product responsibilities, manage the regulatory process, and negotiate with regulatory agencies to provide rapid approvals with competitive labelling. Accountabilities: As a Regulatory Affairs Manager, you will: Identify regulatory strategies to support commercial and business objectives and company efficiencies. Plan and execute workload for the defined product responsibilities and agreeing plan with Regulatory Affairs Lead. Proactively manage the regulatory process and effectively negotiate with regulatory agencies to provide rapid regulatory approvals with competitive labelling. Prepare high quality regulatory applications and regulatory responses for UK (including inputting into summary documents and responses for European applications). Provide regulatory input to commercial, medical affairs, market access, medical information, patient safety and supply chain functions. Ensure timely submission and approvals of licence applications and maintenance activities and compliance with UK regulatory requirements. Assure appropriate standards and policies for all technical aspects of the company's activities in Regulatory Affairs are adhered to. Provide regulatory input/solutions to supply and stock issues. Liaise with Operations to manage pack changes and ensure labelling compliance. Ensure appropriate Regulatory Affairs input into the promotional copy approval process, to ensure that core claims and Prescribing Information are in accordance with the licence. Provide strategic regulatory input relating to AZ promoted and cornerstone brands, including competitor intelligence. Project manage and deliver projects of commercial strategic value. Understand and promote UK business needs into European strategies on drug development and regulatory filings/issues. Ensure appropriate cross-functional input into the delivery of optimal licence strategies. Keep up-to-date with developments in the Regulatory environment and share this knowledge across the department and beyond, in the business interest. Ensure optimal departmental processes through continuous review. Actively contribute to the development, coaching and training of the department, including new starters. Proactively manage the regulatory process for clinical trials for UK. Essential Skills/Experience: Life Sciences Degree or appropriate professional qualifications. Significant experience working within a Regulatory Affairs organisation in a UK-based or Global Pharmaceutical company. Operational regulatory experience in the pharmaceutical industry with time spent in a commercially aware role
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Regulatory Affairs Manager
hace 1 mes
Madrid, España Astrazeneca A tiempo completo.1. MISIÓNImplantar 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. RESPONSABILIDADESGestión y...
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Regulatory Affairs Manager
hace 1 mes
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. RESPONSABILIDADES Gestión y...
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MENA Regulatory Affairs Manager
hace 1 semana
Madrid, Madrid, España Bitfinex A tiempo completoWe are Bitfinex, a pioneering digital asset trading platform, and we are searching for a seasoned professional to join our Regulatory and Licensing team as a MENA Regulatory Affairs Manager. The ideal candidate will have a minimum of 5 years of experience in regulatory affairs within the financial services or crypto-asset industry. They will possess a deep...
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Regulatory Affairs Manager
hace 2 meses
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 2 meses
Madrid, España Astrazeneca Gmbh A tiempo completo.Regulatory Affairs ManagerLocation: London St PancrasCompetitive salary, bonus & benefitsJoin our Biopharmaceuticals Business Unit as a Regulatory Affairs Manager and play a pivotal role in identifying regulatory strategies to support commercial and business objectives. This role offers the opportunity to plan and execute workload for defined product...
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Regulatory Affairs Manager
hace 1 mes
Madrid, España Astrazeneca A tiempo completo1. 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. RESPONSABILIDADES Gestión y...
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Regulatory Affairs Manager
hace 1 mes
Madrid, España Astrazeneca A tiempo completo1. MISIÓNImplantar 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. RESPONSABILIDADESGestión y...
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Regulatory Affairs Manager
hace 2 meses
Madrid, España Astrazeneca Gmbh A tiempo completoRegulatory Affairs ManagerLocation: London St PancrasCompetitive salary, bonus & benefitsJoin our Biopharmaceuticals Business Unit as a Regulatory Affairs Manager and play a pivotal role in identifying regulatory strategies to support commercial and business objectives. This role offers the opportunity to plan and execute workload for defined product...
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Regulatory Affairs Manager
hace 2 meses
Madrid, España Astrazeneca Gmbh A tiempo completoRegulatory Affairs ManagerLocation: London St Pancras Competitive salary, bonus & benefits Join our Biopharmaceuticals Business Unit as a Regulatory Affairs Manager and play a pivotal role in identifying regulatory strategies to support commercial and business objectives. This role offers the opportunity to plan and execute workload for defined product...
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Regulatory Affairs Manager
hace 1 mes
Madrid, España Astrazeneca A tiempo completo1. MISIÓNImplantar 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. RESPONSABILIDADESGestión y...
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Regulatory Affairs Manager CMC Position
hace 2 días
Madrid, Madrid, España Mabxience A tiempo completoCompany OverviewMabxience is a leading biopharmaceutical company dedicated to developing innovative medicines for the global market. Our team of experts is committed to delivering high-quality products that meet the highest regulatory standards.Job SummaryWe are seeking an experienced Regulatory Affairs Manager CMC to join our team in this critical role. The...
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Regulatory Affairs Specialist
hace 2 días
Madrid, Madrid, España Precision Medicine Group A tiempo completoAbout Us">Precision Medicine Group is a leading Clinical Research Organisation that brings together new technologies, expertise, and operational scale to help the life sciences improve the speed, cost, and success rate of bringing life-changing therapies to patients.">Our team has a strong focus on Oncology and Rare Disease, and we're seeking a Regulatory...
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Senior Manager, Regulatory Affairs
hace 4 semanas
Madrid, España Thermo Fisher Scientific A tiempo completo**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - To enable our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed...
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Regulatory Affairs Manager
hace 1 mes
Madrid, España AstraZeneca A tiempo completo1. 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. RESPONSABILIDADES Gestión y...
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Regulatory Affairs Manager
hace 1 mes
Madrid, España Astrazeneca A tiempo completo1. MISIÓNImplantar 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. RESPONSABILIDADESÁreas Clave...
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Regulatory Affairs Manager
hace 7 meses
Madrid, España Grupo Crit A tiempo completo**Descripción**:Desde Grupo Crit buscamos **un REGULATORY AFFAIRS MANAGER** en relación con nuevos productos, nuevos registros, nuevos territorios y proyectos de BD. para una empresa dedicada al suministro de productos farmacéuticos genéricos sobre todo para hospitales ubicada en Alcobendas.**FUNCIONES**:- Será la persona responsable de la expansión en...
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Regulatory Affairs Manager
hace 6 meses
Madrid, España Grupo Crit A tiempo completo**Descripción**: Desde Grupo Crit buscamos **un REGULATORY AFFAIRS MANAGER** en relación con nuevos productos, nuevos registros, nuevos territorios y proyectos de BD. para una empresa dedicada al suministro de productos farmacéuticos genéricos sobre todo para hospitales ubicada en Alcobendas. **FUNCIONES**: - Será la persona responsable de la...
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Regulatory Affairs Specialist
hace 2 semanas
Madrid, Madrid, España Ericsson A tiempo completoJob Title: Regulatory Affairs Specialist at EricssonAbout the Role:We are seeking a highly skilled Compliance Manager to join our team in Sao Paulo, Brazil. As a key member of our organization, you will play a crucial role in ensuring that we maintain the highest standards of compliance and regulatory adherence.About You:To be successful in this position,...
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Junior Manager Regulatory Affairs Cmc
hace 2 días
Madrid, España Mabxience A tiempo completoOverviewThe Junior Manager, Regulatory Affairs CMC is responsible for providing regulatory relevant technical assistance to development teams and ensuring the adequacy of CMC documentation for global regulatory submissions, including specific requirements for regional registration processes.The position supports and promotes all regulatory CMC tasks...
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Junior Manager Regulatory Affairs Cmc
hace 2 meses
Madrid, España Mabxience A tiempo completoOverview: The Junior Manager, Regulatory Affairs CMC is responsible to provide regulatory relevant technical assistance to development teams and ensures adequacy of CMC documentation for global regulatory submissions including specific requirements for regional registration processes. The position supports and promotes all regulatory CMC tasks throughout...
