Regulatory Affairs Manager Ii Urgente

hace 2 semanas

Barcelona, España Astrazeneca Gmbh A tiempo completo

.Job Title: Regulatory Affairs Manager IICareer Level - DIntroduction to roleAre you ready to play a pivotal role in gaining approval for our novel work on unmet medical needs? As a Regulatory Affairs Manager II, you will be a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. You will work flexibly within a Global Regulatory Execution Team (GRET) to manage regulatory affairs, global labeling, and dossier management. This role requires proficiency in applying established standards and the ability to lead cross-functional activities, contributing to the continuous improvement of processes and tools.Accountabilities1. Regulatory Affairs Management- Understands the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.- Provides regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s).- Uses and shares best practices during interactions with health authorities and in day-to-day work.- Leads and/or contributes to the planning, preparation, and delivery of regulatory maintenance submissions.- Liaises closely with cross-functional members with aligned product responsibilities.- Develops, executes, and maintains submission delivery plans and proactively provides status updates to stakeholders.- Identifies regulatory risks and proposes mitigations to Lead RPM and cross-functional teams.- Supports operational and compliance activities for assigned deliverables.- Provides coaching, mentoring, and knowledge sharing within the regulatory organization.- Contributes to process improvement.2. Global Labelling Management- Maintains core labeling documents including the Core Data Sheet and Core Patient Information Leaflet.- Ensures consistency with applicable core labeling documents and internal standards.- Ensures updates to core texts are completed and communicated to Marketing Companies (MCs) in a timely manner.- Maintains repositories of current regional labeling and ensures proper version control.3. Dossier Management- Contributes proactively to resourcing submission deliverables through liaison with internal Global Regulatory Operations or outsourcing partners.- Leads the dossier management deliverables for divestment of products.- Identifies potential regulatory risks to operational plans and proposes options to mitigate risks.- Plans and manages publishing deliverables, as well as associated lifecycle and license information.- Develops and maintains strong partnerships with internal and external customers and partners.Essential Skills/ExperienceRelevant University Degree in Science or related discipline.Minimum 8 years of relevant Regulatory experience within the biopharmaceutical industry, including license maintenance, labelling, and publishing, and of working in regulated markets

  • Regulatory Affairs Manager Ii

    hace 2 semanas

    Barcelona, España Astrazeneca Gmbh A tiempo completo

    .Job Title: Regulatory Affairs Manager II Career Level - D Introduction to role Are you ready to play a pivotal role in gaining approval for our novel work on unmet medical needs? As a Regulatory Affairs Manager II, you will be a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and...

  • Regulatory Affairs Manager Ii

    hace 2 semanas

    Barcelona, España Astrazeneca Gmbh A tiempo completo

    Job Title: Regulatory Affairs Manager II Career Level - D Introduction to role Are you ready to play a pivotal role in gaining approval for our novel work on unmet medical needs? As a Regulatory Affairs Manager II, you will be a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and...

  • Regulatory Affairs Manager Ii

    hace 2 semanas

    Barcelona, España Astrazeneca Gmbh A tiempo completo

    .Job Title: Regulatory Affairs Manager IICareer Level - DIntroduction to roleAre you ready to play a pivotal role in gaining approval for our novel work on unmet medical needs? As a Regulatory Affairs Manager II, you will be a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and...

  • Regulatory Affairs Manager Ii

    hace 2 semanas

    Barcelona, España Astrazeneca Gmbh A tiempo completo

    .Job Title: Regulatory Affairs Manager IICareer Level - DIntroduction to roleAre you ready to play a pivotal role in gaining approval for our novel work on unmet medical needs? As a Regulatory Affairs Manager II, you will be a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and...

  • Regulatory Affairs Manager Ii

    hace 2 semanas

    Barcelona, España Astrazeneca Gmbh A tiempo completo

    Job Title: Regulatory Affairs Manager IICareer Level - DIntroduction to roleAre you ready to play a pivotal role in gaining approval for our novel work on unmet medical needs? As a Regulatory Affairs Manager II, you will be a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and...

  • Regulatory Affairs Manager Ii

    hace 2 semanas

    Barcelona, España Astrazeneca Gmbh A tiempo completo

    Job Title: Regulatory Affairs Manager IICareer Level - DIntroduction to roleAre you ready to play a pivotal role in gaining approval for our novel work on unmet medical needs? As a Regulatory Affairs Manager II, you will be a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and...

  • Regulatory Affairs Manager II

    hace 2 semanas

    Barcelona, España AstraZeneca GmbH A tiempo completo

    Job Title: Regulatory Affairs Manager II Career Level - D Introduction to role Are you ready to play a pivotal role in gaining approval for our novel work on unmet medical needs? As a Regulatory Affairs Manager II, you will be a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and...

  • Regulatory Affairs Manager

    hace 9 horas

    Barcelona, España ARTHADA A tiempo completo

    **ARTHADA**, a leading company in offering specialised HR services to the pharmaceutical sector, is recruiting for an international pharmaceutical company focused on medical devices a **REGULATORY AFFAIRS MANAGER (Barcelona)** - A bachelor’s degree in science is required. - More than 5-year experience required in the field of regulatory affairs in...

  • Regulatory Affairs

    hace 6 meses

    Barcelona, España Hays A tiempo completo

    **Tu nueva empresa** Nuestro cliente es una empresa en pleno crecimiento que se dedica a la investigación de ingredientes patentados para su aplicación en diferentes sectores: alimentación, salud y nutrición. **Tu nuevo puesto** Estamos buscando perfiles como Regulatory Affairs Manager & Regulatory Affairs Technician, cuyo objetivo será el de...

  • Regulatory Affairs

    hace 6 meses

    Barcelona, España Hays A tiempo completo

    **Tu nueva empresa**Nuestro cliente es una empresa en pleno crecimiento que se dedica a la investigación de ingredientes patentados para su aplicación en diferentes sectores: alimentación, salud y nutrición.**Tu nuevo puesto**Estamos buscando perfiles como Regulatory Affairs Manager & Regulatory Affairs Technician, cuyo objetivo será el de asegurar el...

  • Global Regulatory Affairs Manager

    hace 6 meses

    Barcelona, España MCR International A tiempo completo

    Descripción del Trabajo / Job Description - MFC-2402-62 GLOBAL REGULATORY AFFAIRS MANAGER BARCELONA Position Summary Innovative international specialty pharma Company that invests in the development of new treatments for patients through partnerships with third parties. A broad therapeutic portfolio provides help to many patients in need. Although the...

  • Regulatory Affairs Manager

    hace 6 meses

    Barcelona, España Hays A tiempo completo

    **Tu nueva empresa** Reconocido y posicionado Laboratorio - Compañía Farmacéutica, ubicada a escasos KM de Barcelona. **Tu nuevo puesto** Te incorporarás como Head Of Regulatory Affairs / Manager del departamento de RA. Labores de coordinación, supervisión y organización pasando por: - Planificar los expedientes de registro. - Mantenimiento y...

  • Regulatory Affairs Manager

    hace 3 semanas

    Barcelona, Barcelona, España Sandoz A tiempo completo

    About the RoleWe seek a highly skilled Manager Regulatory Affairs API to join our team at Sandoz.Main Responsibilities:Formulate and lead global regulatory strategy for drug substances under minor supervisionProvide timely preparation of high-quality CMC regulatory documentationDevelop innovative solutions and manage complex activities for gaining and...

  • Regulatory Affairs Manager, Vaccines

    hace 6 meses

    Barcelona, España AstraZeneca A tiempo completo

    **Job Title**:Regulatory Affairs Manager, Vaccines & Immune Therapies** **Number of positions**: 3 **Grade E** **Location**:Barcelona, Spain **Salary**: Competitive & Excellent Benefits Package **Introduction to role** Are you passionate about **science** and experienced within **drug development** and **regulatory affairs**_? _Would you like to...

  • Regulatory Affairs

    hace 6 meses

    Barcelona, España Hays A tiempo completo

    **Tu nueva empresa** Reconocido Laboratorio Farmacéutico ubicado a escasos KM de Barcelona. **Tu nuevo puesto** Precisamos incorporar un perfil de Regulatory Affairs - Técnico de Registros Tus funciones serán las siguientes: - Elaborar, mantener y actualizar los dossiers de los medicamentos y los expedientes técnicos de los productos de la...

  • Regulatory Affairs

    hace 6 meses

    Barcelona, España Hays A tiempo completo

    **Tu nueva empresa**Reconocido Laboratorio Farmacéutico ubicado a escasos KM de Barcelona.**Tu nuevo puesto**Precisamos incorporar un perfil de Regulatory Affairs - Técnico de RegistrosTus funciones serán las siguientes:- Elaborar, mantener y actualizar los dossiers de los medicamentos y los expedientes técnicos de los productos de la empresa.- Colaborar...

  • Regulatory Affairs Associate

    hace 2 semanas

    Barcelona, España buscojobs España A tiempo completo

    Regulatory Affairs AssociateBarcelona, CataloniaGalderma - 28.11.2024With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative approach to dermatological care.Regulatory Affairs AssociateBarcelona, CataloniaGlobal...

  • Regulatory Affairs Associate

    hace 2 semanas

    Barcelona, España buscojobs España A tiempo completo

    Regulatory Affairs AssociateBarcelona, CataloniaGalderma - 28.11.2024With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative approach to dermatological care.Regulatory Affairs AssociateBarcelona, CataloniaGlobal...

  • Regulatory Affairs Specialist

    hace 3 semanas

    Barcelona, Barcelona, España Werfen A tiempo completo

    The Regulatory Affairs department at Werfen is seeking a highly skilled Quality and Regulatory Affairs specialist to join our team in Barcelona, Spain.As a Quality and Regulatory Affairs specialist, you will be responsible for supporting the execution of pre and post-market regulatory affairs departmental functions. This includes assisting in the preparation...

  • Regulatory Affairs Junior

    hace 6 meses

    Barcelona, España Page Personnel España A tiempo completo

    Técnico/a para la preparación de la documentación regulatoria de los productos desarrollados por la empresa, complementos alimenticios, productos sanitarios clase IIa, productos sanitarios in vitro y cosméticos. Formación en Ciencias de la Salud|Prácticas en RA y/o Máster en Registros - Formación en Ciencias de la Salud: Farmacia, biología,...