Regulatory Affairs Manager, Vaccines
hace 7 días
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 combine your project management skills with your experience of working cross functionally and globally?
At AstraZeneca, we are driven by innovation and our dedication to make a real-life difference in patients' lives. That difference starts with you. We need people who share our passion for science and determination to meet patients' needs around the world. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality.
Does this match your skills and ambitions for the future? Then join us to be part of the development of innovative Vaccines and Immune Therapies for the prevention and treatment of Infectiousdiseases.
We are now looking for passionate colleagues to join our Regulatory Project Management team as a Regulatory Affairs Manager (RAM).
With us, you will have the opportunity to work across the spectrum of drug development to progress a rich and diverse pipeline.
The role is based at AstraZeneca's dynamic R&D site in Barcelona.What you'll do The Regulatory Affairs Manager (RAM) is a global regulatory specialist with project management capabilities responsible for leading / contributing to the end-to-end planning, coordination, and execution of assigned deliverables.
The RAM manages delivery of submissions to time, quality, and in compliance with applicable regulations.The RAM is a contributor to regulatory submission strategy,identifying submission risks and opportunities, while leading regulatory submissions and managing procedures through approval.
The RAM provides regulatory expertise and guidance on procedural and documentation requirements to Regulatory and cross-functional teams working globally to ensure the delivery of business objectives.
Accountabilities/Responsibilities Provide regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including:Develop, execute and maintain submission delivery plans, submission content plans, support operational and compliance activities for assigned deliverables and proactively provide status updates to designated stakeholders.
Lead and/or contribute to the planning, preparation and delivery of both simple and complex submissions throughout the product's life cycle from either a global and/or regional perspective.
Contribute to Submission delivery strategyReview documents for compliance with applicable internal policies and regulations(e.g study protocols, Periodic Safety Reports, etc.)
Identify regulatory risks and communicate mitigations to Regulatory lead and cross functional teams.
Understand the regulatory framework, including regional trends, for various types of applications and procedures spanning a product's lifecycle for small and large molecules globally.
Provide coaching, mentoring and knowledge sharing within the Regulatory Affairs Management skill group.Contribute to process improvement to maintain and continuously improve regulatory consistency.
Oversee general Regulatory compliance in assigned markets/regions and escalate any compliance issues.
Essential for the role Relevant University Degree in Science or related discipline
Regulatory experience within the biopharmaceutical industry, experience at a health authority, or other relevant experience.
General knowledge of drug development
Strong project management skills
Leadership skills, including experience leading multi-disciplinary project teams
Excellent written and verbal communication skills
Cultural awareness
Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions
Ability to work independently and as part of a team
Influencing and stakeholder management skills
Ability to analyze problems and recommend actions
Continuous Improvement and knowledge sharing focused
Desirable for the role Managed regulatory deliverables across projects/products
Detailed knowledge of the drug development process
-
Regulatory Affairs Manager, Vaccines
hace 7 días
Barcelona, Barcelona, España AstraZeneca GmbH A tiempo completoJob Title:Regulatory Affairs Manager, Vaccines & Immune Therapies Number of positions: 3Grade ELocation: Barcelona, SpainSalary: Competitive & Excellent Benefits PackageIntroduction to roleAre you passionate about science and experienced within drug development and regulatory affairs? Would you like to combine your project management skills with your...
-
Regulatory Affairs Manager
hace 7 días
Barcelona, Barcelona, España Robert Walters A tiempo completoRobert Walters is hiring a Regulatory Affairs Manager in Barcelona.Our client is an important pharmaceutical company specialized in medical nutrition.As a Regulatory Affairs Manager, the candidate reports to the Director of RD&A.Its objective is to ensure regulatory compliance of the product portfolio (marketed and investigational products) in all the...
-
Regulatory Affairs Manager
hace 2 meses
Barcelona, Barcelona, España Robert Walters A tiempo completoRobert Walters is hiring a Regulatory Affairs Manager in Barcelona.Our client is an important pharmaceutical company specialized in medical nutrition.As a Regulatory Affairs Manager, the candidate reports to the Director of RD&A.Its objective is to ensure regulatory compliance of the product portfolio (marketed and investigational products) in all the...
-
Regulatory Affairs Manager
hace 7 días
Barcelona, Barcelona, España Robert Walters Spain A tiempo completoRobert Walters is hiring a Regulatory Affairs Manager in Barcelona.Our client is an important pharmaceutical company specialized in medical nutrition.As a Regulatory Affairs Manager, the candidate reports to the Director of RD&A.Its objective is to ensure regulatory compliance of the product portfolio (marketed and investigational products) in all the...
-
Regulatory Affairs Manager
hace 7 días
Barcelona, Barcelona, España Innovaderm Research A tiempo completoThe Manager, Regulatory Affairs is responsible to ensure the services provided by the regional regulatory affairs department are conducted according to Innovaderm's standard operating procedures, applicable regulations and good clinical practices and to the Sponsor's satisfaction. Responsibilities include providing leadership on regulatory activities that...
-
Global Regulatory Affairs Manager
hace 7 días
Barcelona, Barcelona, España MCR International A tiempo completodel Trabajo / Job Description MFCGLOBAL REGULATORY AFFAIRS MANAGERBARCELONA 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 Company is focused on...
-
Regulatory Affairs Manager
hace 4 semanas
Barcelona, Barcelona, España Randstad España A tiempo completoDesde Randstad estamos buscando un/a candidato/a para realizar las tareas de Regulatory Affairs Manager para una empresa situada en Cataluña Central. En dicha posición estarás en dependencia de Dirección Técnica y tendrás a cargo 2 personas.Responsabilidades clave:Supervisión de Cumplimiento Regulatorio: Asegurar que todos los productos y procesos...
-
Regulatory Affairs Manager
hace 7 días
Barcelona, Barcelona, España Randstad España A tiempo completoDesde Randstad estamos buscando un/a candidato/a para realizar las tareas de Regulatory Affairs Manager para una empresa situada en Cataluña Central. En dicha posición estarás en dependencia de Dirección Técnica y tendrás a cargo 2 personas.Responsabilidades clave:Supervisión de Cumplimiento Regulatorio: Asegurar que todos los productos y procesos...
-
Regulatory Affairs Manager
hace 3 semanas
Barcelona, Barcelona, España Randstad España A tiempo completoDesde Randstad estamos buscando un/a candidato/a para realizar las tareas de Regulatory Affairs Manager para una empresa situada en Cataluña Central. En dicha posición estarás en dependencia de Dirección Técnica y tendrás a cargo 2 personas.Responsabilidades clave:Supervisión de Cumplimiento Regulatorio: Asegurar que todos los productos y procesos...
-
Senior Regulatory Affairs
hace 7 días
Barcelona, Barcelona, España Antal International Network A tiempo completoDesde el departamento de Pharma de Antal International nos encontramos en búsqueda de un Senior Regulatory Affairs para trabajar en una importane multinacional Dermocosmética para la parte de regulación de medicamentos ubicada en Barcelona. Formación Universitaria en Ciencias de la SaludMás de 4 años con posiciones de Regulatory Affairs en Industria...
-
Regulatory Affairs Director
hace 7 días
Barcelona, Barcelona, España AstraZeneca A tiempo completoAre you a strategically focused Regulatory Affairs professional and would like to play an integral part in crafting drug development and gaining fast, efficient approvals? If so, read on...At AstraZeneca, we have a team united by a shared passion to learn, grow and discover.This role, as a Regulatory Affairs Director (RAD), provides strategic and operational...
-
Senior Regulatory Affairs
hace 7 días
Barcelona, Barcelona, España Antal International Network A tiempo completoDesde el departamento de Pharma de Antal International nos encontramos en búsqueda de un Senior Regulatory Affairs para trabajar en una importane multinacional Dermocosmética para la parte de regulación de medicamentos ubicada en BarcelonaRequisitos:Formación Universitaria en Ciencias de la SaludMás de 4 años con posiciones de Regulatory Affairs en...
-
Senior Regulatory Affairs
hace 7 días
Barcelona, Barcelona, España Antal International Network A tiempo completoDesde el departamento de Pharma de Antal International nos encontramos en búsqueda de un Senior Regulatory Affairs para trabajar en una importane multinacional Dermocosmética para la parte de regulación de medicamentos ubicada en Barcelona.Requisitos:Formación Universitaria en Ciencias de la Salud Más de 4 años con posiciones de Regulatory Affairs en...
-
Regulatory Affairs
hace 7 días
Barcelona, Barcelona, España CREACIONES AROMATICAS INDUSTRIALES, S.A. A tiempo completoGrupo Carinsa, con más de 30 años de experiência en el sector de las fragancias y los aromas, busca perfil de Regulatory AffairsSe responsabilizará de elaborar la documentación técnica relativa a los productos fabricados por la empresa, por lo que deberá conocer la normativa vigente, relacionada con clasificación y envasado de productos químicos....
-
Regulatory Affairs Trainee
hace 7 días
Barcelona, Barcelona, España HARTMANN A tiempo completoÚnete a nuestro equipo comoRegulatory Affairs TraineeESP-Mataró (Barcelona)Aprovecha la nueva oportunidad que te ofrece HARTMANN en el Área de Regulatory Affairs.Responsabilidades En relación con las comunicaciones de puesta en el mercado a la AEMPS por cada producto sanitario que ponemos en el mercado:Reunir la documentación técnica y su revisión....
-
Regulatory Affairs
hace 7 días
Barcelona, Barcelona, España CREACIONES AROMATICAS INDUSTRIALES, S.A. A tiempo completoGrupo Carinsa, con más de 30 años de experiência en el sector de las fragancias y los aromas, busca perfil de Regulatory AffairsSe responsabilizará de elaborar la documentación técnica relativa a los productos fabricados por la empresa, por lo que deberá conocer la normativa vigente, relacionada con clasificación y envasado de productos químicos....
-
Trainee Regulatory Affairs
hace 7 días
Barcelona, Barcelona, España Angelini Pharma España A tiempo completoDentro del Departamento de Regulatory Affairs & QA, la posición de Trainee Regulatory Affairs **está enfocada a dar soporte principalmente el área de Regulatory Affairs en el cumplimiento de los estándares de calidad de los productos comercializados de acuerdo con la normativa vigente a nível nacional y europeo y las directrices establecidas por la...
-
Regulatory affairs junior
hace 2 meses
Barcelona, Barcelona, España Page Personnel A tiempo completoActualizado 10/04/2024 Formación en Ciencias de la Salud Master en Regulatory Affairs o prácticas en Regualtory Affairs¿Dónde vas a trabajar?Importante compañía con sede en Vallés Occidental, centrada en el desarrollo y la fabricación de productos sanitarios y complementos alimenticios innovadores¿Qué harás en tu nuevo puesto?Técnico/a para la...
-
Regulatory Affairs Junior
hace 7 días
Barcelona, Barcelona, España Page Personnel España A tiempo completoTécnico/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,...
-
Regulatory Affairs Biosimilars Manager
hace 7 días
Barcelona, Barcelona, España Winid A tiempo completoWinid is a game-changer that puts TALENT SOURCING at the heart of its business model.We firmly believe that talented people are the crucial element for the success of organizations. We understand it as Augmented Talent by putting technology and AI at the service of people.We aim to reach excellence in attracting, training, and equipping the finest talent...
