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 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. Accountabilities 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. 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. 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/Experience Relevant 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 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 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...

  • Regulatory Affairs Manager

    hace 22 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,...