Salario: Regulatory Affairs Mánager en Barcelona

¿Tienes experiencia previa como Regulatory Affairs Specialist?, ¿tienes experiencia en enfrentar y resolver desafíos regulatorios en un entorno dinámico?, ¿estás acostumbrado a asesorar sobre la clasificación adecuada de ingredientes y productos en función a las regulaciones vigentes? ¡Tenemos una propuesta para ti!Desde Eladiet, precisamos un Regulatory Affairs Specialist para nuestro Departamento de Regulatorio.¿Quiénes somos?Somos una empresa familiar ubicada en El Papiol (Barcelona) en la que, tras 35 años de apasionante trabajo, más de 140 personas colaboran a diario en el desarrollo de complementos alimenticios naturales, innovadores y eficaces.¿Cuáles serán tus funciones?Asegurar el cumplimiento de los requisitos legales vigentes aplicables a los productos y a la empresa.Custodiar y actualizar la documentación regulatoria (proveedores, autoridades sanitarias y entidades certificadoras, etc).Dar soporte regulatorio en la fabricación de productos para terceros desde el desarrollo hasta la fabricación y post comercialización.Solicitud de certificados de registros sanitarios, certificados APPCC, etc.Contribuir a la mejora continua de procesos y herramientas de trabajo aplicables al departamento.¿Qué esperamos de ti?Graduado/a en Farmacia con máster en la industria farmacéutica y parafarmacéutica o similar.Experiencia mínima de 3 años como técnico de registros en industria farmacéutica o similar.Nivel de inglés avanzado.¿Por qué Eladiet?Formarás parte de una empresa líder de un sector a fin al farmacéutico. A la vanguardia en la gestión de personas con talento.Trabajaras con un equipo joven y dinámico, en una empresa puntera en tecnología.Dispondrás de flexibilidad horaria desde el primer día.Disfrutarás de nuestras oficinas Open Space, rodeadas de naturaleza y diseño.Te ofreceremos formación On Boarding y continuada, además de clases de inglés totalmente gratuitas.¿Más beneficios? ¡Por supuesto!También de café gratuito todos los días.Disfrutarás de una sala con futbolín.¿Te atreves a aceptar nuestro reto?, ¡inscríbete, queremos conocerte!Conócenos mejor en:www.eladiet.comInstagram: @eladiet_#vivirnaturalmente

Join our global team dedicated to innovation and initiative, where physical walls and different time zones dont limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.Job Description SummaryJob DescriptionTHE DIRECTOR ROLE, REGULATORY AFFAIRSThe Director, Regulatory Affairs Medtech is a critical member of the Alira Health project team. The Director will work closely with Managers and VP and work with clients to guide, write and streamline regulatory projects. The Director will help to set direction for clients in the coordination, execution, guidance and implementation of regulatory programs, requirements and compliance activities. The individual will be a key resource for all regulatory activities.The main focus of the Director will be to work on EU and FDA-related projects. Expertise in both markets is not a must, but it is preferred if the Director is willing to continue learning in case of lower expertise in one of both markets before mentioned.ESSENTIAL JOB FUNCTIONSBe hands-on on planning, organizing, executing, writing and delivering projects.Monitor and analyze the impact of emerging or revised laws, regulations, enforcement actions and other changes that impact the manner by which the clients' products are regulated around the world.Plan, manage, prepare and submit EU/NB-related submissions: Roadmaps, Gap Analysis, Product categorization, Technical Documentation compilation, Response to non-conformities, etc.Plan, manage, prepare and submit FDA-related submissions: RFD, Pre-Submissions, 510(k), De Novo, PMA, IDE, BDD, etc.Provide, as needed, regulatory strategic support and direction to client programs and initiatives.Design and implement regulatory strategies to obtain, maintain and extend product registrations for new device/combination product/companion diagnostic portfolios.Oversee the development and submission of regulatory filings to FDA and EUServe as liaison with regulatory agencies.Lead core regulatory activities to ensure effective agency interactions that are consistent with clients regulatory strategies.Provide regulatory guidance and input to clients.Provide regulatory operations and electronic submissions support.Performs additional duties as assigned.PREPARATION, KNOWLEDGE, SKILLS ABILITIESBS/BA from a top undergraduate program in a scientific discipline.10+ years experience in a regulatory role within medical device sector.Knowledge of appropriate regulations within the specific sector.Previous experience in consulting will be favorably valued.Knowledge of FDA procedures.Knowledge of MDR and IVDR.Strong analytical skills and ability to problem-solve unstructured or ambiguous challenges.Demonstrated ability to communicate complex information and analyses to a variety of audiences.The role for Director requires ability to work hands-on on the execution and delivery of the projects.Strong command of English, both written and verbal.Excellent communication and interpersonal skills with client service orientation.Advanced skills in MS Office Suite, particularly Word.Thrives in collaborative, yet less structured team environment.We will not sponsor work visas.WORKING CONDITIONS/PHYSICAL DEMANDSNormal office working conditions including frequent sitting, standing, bending, twisting and computer monitor use.LanguagesEnglishEducationContract TypeRegularSummaryLocation: Barcelona; Barcelona-RemoteType: Full time

LAR-2404-127TCNICO SENIOR REGULATORY AFFAIRS TCNICO RESPONSABLE ADJUNTOBARCELONADesde MCR International estamos en bsqueda de un Tcnico Senior de Regulatory Affairs Tcnico Responsable Adjunto en Barcelona, para una importante empresa farmacutica en pleno crecimiento. Descripcin del puesto Realizar las actividades relacionadas con los Asuntos Regulatorios para mantener el portfolio de medicamentos de la compaa Asumir el papel de Tecnico Responsable Adjunto garantizando el cumplimiento de todos los requerimientos legales para la comercializacin de los productos Principales Responsabilidades y Funciones:Regulatory Affairs Realizar y/o colaborar el seguimiento y obtencin de las autorizaciones de comercializacin o de sus consecuentes modificaciones para productos corporativos y locales Preparacin, revisin, presentacin de los expedientes (nuevos registros, revalidaciones, variaciones, suspensiones) incluyendo revisin lingstica de los materiales Asegurar que se d una respuesta rpida y completa a cualquier solicitud de informacin de la AEMPS a posibles alegaciones Acceder y mantener actualizado los sistemas de seguimiento de la informacin internos como externos de seguimiento de la informacin (RAEFAR, CESP, Extedo) Establecer, mantener y potenciar la relacin con la Autoridades Sanitarias, para conseguir el asesoramiento, clarificacin, discusin de asuntos regulatorios. Establecer, mantener y potenciar la relacin con Global Regulatory Affairs y las diferentes Unidades de Negocio Colaborar para la definicin de la estrategia de la gestin del ciclo de vida (LCM) de los productos y participar en la revisin aprobacin de la documentacin tcnica del departamento Tcnico Responsable Adjunto Asegurar el suministro continuado de los productos de la compaa medicamento, producto sanitario y complemento alimenticio Autorizar la puesta en el mercado de cada lote de, de acuerdo con la documentacin entregada y los requisitos locales Autorizar los movimientos de stocks (liberacin, devoluciones) Informar a las Autoridades Sanitarias de cualquier interrupcin de suministro y gestionar medicamentos en situaciones especiales Participar en posible retirada de lotes del mercado y comunicacin con las autoridades competentes Actuar como interlocutor frente a las Autoridades Sanitarias en todos los temas referentes a la fabricacin y/o distribucin de los productos. Asegurar que las operaciones de fabricacin y/o distribucin de medicamentos se realizan de acuerdo a su Autorizacin de Comercializacin, y que todos los cambios sean aprobados por las Autoridades Sanitarias siguiendo el procedimiento de modificacin de autorizaciones. Colaborar en el desarrollo y mantenimiento del Sistema de Calidad de la ca, desarrollo de procedimientos, informes de producto, KPIs Formacin requerida Licenciatura en Farmacia Postgrado o formacin especfica en registros en general, legislacin farmacutica. 10 aos de experiencia en puesto similar Idiomas: Espaol, Ingls nivel alto, se valora conocimiento en portugus Habilidades especficas del puesto Conocimiento exhaustivo de la legislacin europea como espaola para puesta en el mercado de medicamentos Ordenado, estructurado y planificador Pensamiento analtico, Solucin de problemas.Employment typeFULL TIME

Associate DirectorGlobal Regulatory Affairs Development Location:Paris, FRJob Profile:Director, Development Strategy, US LeadReports To:Executive Director, Regulatory Affairs Development Strategy, Neurology and OphthalmologyDate:February 2024This is what you will do:[Definition: Position Summary]The Associate Director, Global Regulatory Affairs Development Strategy (GRA-DS) will be responsible for developing and implementing regulatory strategy leading to successful registration and life-cycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs.This individual will, with a high sense of urgency, provide operational and strategic regulatory input to cross-functional teams responsible for global programs.The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.You will be responsible for:[Definition: Job Duties and Responsibilities]Serve as regulatory strategy lead within EU/designated region(s) on assigned program. May serve as global regulatory team leader on assigned programs.Develop and direct innovative and effective regulatory strategies in support of assigned Alexion portfolio, pipeline and therapeutic areas.Provide advice on regulatory issues for both marketed and pipeline products; actively collaborates with management and cross functional colleagues within Alexion (i.E., commercial, research, clinical development, medical affairs, business development, legal, manufacturing, quality, portfolio management, financial, human resources, etc.).Prepare and execute region-specific aspects of regulatory affairs and ensure integration into global regulatory strategy.Represent Alexion as point of contact with regulatory authorities, including providing support for and coordination of regulatory meetings and information package development. Coordinate submissions to regulatory authorities in support of proposed and ongoing development programs, e.G., new clinical trial application submissions, amendments, etc. Monitor the development of new regulatory requirements or guidance documents and advise product teams of the impact on the business or development programs.Ensure exemplary behavior, ethics, and transparency within the company and with regulatory agencies.You will need to have:[Definition: Essential Qualifications. The minimum skills and requirements needed for the position]QualificationsStrong knowledge of drug development and regulatory policy; excellent scientific and business judgment.Experience providing strategic regulatory advice for the global and/or EU development of products through all stages of development including pre-approval and marketed compounds.Experience in leading Health Authority InteractionsAbility to manage complex issues and coordinate multiple projects simultaneouslyAbility to build intra-team relationships and collaborate in a global team environment at all levels of the organization. Strong interpersonal, and written/verbal communication skills.Proven track record practicing sound judgment as it relates to risk assessmentHighly conversant and knowledgeable of new and emerging regulations and guidances. Understanding of GMPs, GLPs and GCPs; solid understanding of where to seek and how to interpret regulatory information.EducationBachelors Degree in a related discipline7 years in pharmaceutical industry regulatory affairsCompetencesEnsure AccountabilityCollaborateCultivate InnovationBei ResilientLearning and Self-DevelopmentDate Posted01-Mar-2024Closing DateAlexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact [email protected]. Alexion participates in E-Verify.SummaryLocation: France - Levallois Perret; Spain - BarcelonaType: Full time