Regulatory Affairs Associate

hace 2 semanas

España Galderma A tiempo completo

With 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, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermo-cosmetics, and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we’re in shapes our lives, we are advancing dermatology for every skin story. We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee. At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact. Further supporting our growth and innovation momentum, we are establishing a new Global Capability Center in Barcelona to deploy new capabilities to effectively support its global commercial and functional teams. Located in the upscale Eixample District in the heart of Barcelona, Galderma’s Global Capability Center offers numerous possibilities for professional development such as exposure to global and cross-functional projects and access to global career opportunities. Job Title: Specialist, Regulatory Affairs Strategy Location: Barcelona, Spain (hybrid) Job Description The Regulatory Affairs Strategist delivers innovative, breakthrough global regulatory strategies for clinical trial registration with health authorities. The RA Strategist is responsible for regulatory aspects related to clinical trial regulatory submissions in alignment with the global business strategy and in partnership with the functional subject matter experts within the Global R&D. Key ResponsibilitiesCreating and managing clinical trial regulatory strategy for biologics, executing clinical trial regulatory activities in alignment with agreed clinical timelines, including responses to health authority queries, amendments to clinical trial dossiers, regulatory SUSAR reporting, or any other regulatory activities as needed. Oversight of clinical trial regulatory submissions, ensuring accurate and compliant dossiers. Archiving clinical trial documentation. Managing health authority interaction for assigned regions in alignment with agreed regulatory strategy. Identifying and assessing risks associated with the clinical regulatory submissions and recommend strategies to mitigate these risks. Providing regular updates to global regulatory lead and indication regulatory leads regarding specific clinical trials. Managing of outside vendors. Skills & QualificationsKnowledge and understanding of regulatory requirements for pharmaceutical/biological product development. Experience with performing regulatory submissions in at least one key regulatory region. Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies. Experience interfacing with regulatory agencies and skill at implementing successful regulatory strategies. Experience with documenting regulatory strategies in coordination with clinical plans and marketing objectives. Excellent team interaction skills along with demonstrated ability to work on a cross-functional team. Ability to identify opportunities/major issues and to communicate impact. Demonstrated ability to deal with rapid change. What we offer in returnYou will be working for an organization that embraces diversity & inclusion and believes we will deliver better outcomes by reflecting the perspectives of our diverse customer base. You will receive a competitive compensation package with bonus structure and extended benefit package. You will be able to work in a hybrid work culture. You will participate in feedback loops, during which a personalized career path will be established. You will be joining a growing company that believes in ownership from day one where everyone is empowered to grow and to take on accountability. Next StepsIf your profile is a match, we will invite you for a first virtual conversation with the recruiter. The next step is a virtual conversation with the hiring manager. The final step is a panel conversation with the extended team. Our people make a differenceAt Galderma, you’ll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.
#J-18808-Ljbffr

  • Associate Director, Regulatory Affairs

    hace 2 semanas

    España Cpl Healthcare A tiempo completo

    Job Title: Associate Director, Regulatory Affairs - Medical Device/Post-Market SurveillanceJob Type: Full Time, Permanent PositionLocation: Spain, Madrid – HybridRemuneration: Attractive salary and packageAn exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology. Due to...

  • Regulatory Affairs Associate

    hace 2 semanas

    España Galderma Pharma S.A A tiempo completo

    Regulatory Affairs Associate With 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, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology...

  • Regulatory Affairs Associate Director

    hace 2 semanas

    España Sandoz A tiempo completo

    As Regulatory Affairs Associate Director, you will lead associates within Regulatory API (RAPI), accountable for driving and delivering high quality documentation supporting successful submission, within agreed timelines and project planes. Including preparation of registration documentation and assessment of appropriateness of registration documentation for...

  • Regulatory Affairs Associate

    hace 3 días

    España buscojobs España A tiempo completo

    Global Life Science Hub has partnered with a one-of-a-kind, global CDMO that specializes in providing comprehensive development and manufacturing services. With an additional 50% growth expected in Europe site, we’re searching for a Regulatory Affairs Associate who will manage the relationships with key suppliers and build your own technical specialization...

  • Regulatory Affairs Associate

    hace 1 semana

    España Global Life Science Hub A tiempo completo

    Global Life Science Hub has partnered with a one-of-a-kind, global CDMO that specializes in providing comprehensive development and manufacturing services. With an additional 50% growth expected in Europe site, we’re searching for a Regulatory Affairs Associate who will manage the relationships with key suppliers and build your own technical specialization...

  • Chemical Regulatory Affairs Associate

    hace 2 semanas

    España W. L. Gore & Associates, Inc A tiempo completo

    Gore Associates, please login to view internal opportunities and refer candidates.Chemical Regulatory Affairs Associate (f/m/d)About the Role: We are looking for a Chemical Regulatory Affairs Associate (f/m/d) to join our Fabrics team. In this role, you will focus on EMEA chemical control regulations enabling the use, development, and movement of chemicals...

  • Regulatory Affairs Associate

    hace 5 días

    España Galderma A tiempo completo

    With 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, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable...

  • Regulatory Affairs Associate

    hace 22 horas

    España Galderma A tiempo completo

    With 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, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable...

  • Trainee Regulatory Affairs

    hace 2 días

    España Angelini Pharma España A tiempo completo

    Dentro 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...

  • Regulatory Affairs Junior

    hace 3 días

    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,...

  • Regulatory Affairs Manager

    hace 3 días

    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...

  • Regulatory Affairs

    hace 2 días

    España Formel D A tiempo completo

    Formel D es el proveedor de servicios global para la industria. Desarrollamos conceptos líderes en el mercado, así como soluciones individuales y escalables a lo largo de toda la cadena de valor del proceso productivo, desde la fase de diseño, industrialización, producción y postventa. La compañía fue fundada en 1993 y tiene su sede en Colonia...

  • Regulatory Affairs Manager

    hace 2 semanas

    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...

  • Associate Director of Translational Regulatory Science

    hace 2 semanas

    España AstraZeneca A tiempo completo

    Associate Director of Translational Regulatory ScienceWithin Oncology Regulatory Science, Strategy & Excellence (ORSSE), we bring hope and solutions to patients across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We...

  • Trainee Regulatory Affairs

    hace 3 días

    España Grifols, S.A A tiempo completo

    ¿Te gustaría unirte a un equipo internacional que trabaja para mejorar el futuro del sector de la salud? ¿Quieres contribuir a mejorar la vida de millones de personas? Grifols es una compañía global del sector de la salud que desde 1909 mejora la salud y el bienestar de las personas en todo el mundo. Somos líderes en medicamentos hemoderivados y...

  • Regulatory Affairs Specialist

    hace 2 semanas

    España Michael Page ES A tiempo completo

    Reporting to the Regulatory Affairs Director, the Regulatory Affairs Specialist will be primarily responsible for:The preparation, submission, monitoring and updating of regulatory dossiers.Prepare high quality regulatory dossiers (novel food, enzymes, GRAS, etc.) needed for the marketing of our products or those of our business partners in different...

  • Regulatory Affairs

    hace 3 días

    España CREACIONES AROMATICAS INDUSTRIALES, S.A. A tiempo completo

    Grupo Carinsa, con más de 30 años de experiência en el sector de las fragancias y los aromas, busca perfil de Regulatory Affairs Se 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....

  • Vice President, Regulatory Affairs

    hace 2 semanas

    España Precision Medicine Group A tiempo completo

    Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought 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. What sets us apart is the way we integrate clinical trial execution with deep scientific...

  • Regulatory Affairs Junior

    hace 2 días

    España Uriach A tiempo completo

    **¿Quieres formar parte de nuestro equipo de **Regulatory Affairs**? Si tienes....**: Interés en Regulatory Affairs del sector Consumer Healthcare y eres **Tus Retos**: Tu **Misión **es controlar el cumplimiento con la legislación de los productos asignados, de acuerdo con las directrices del Responsable de Registros y el marco legal vigente, con el fin...

  • Regulatory Affairs Intern

    hace 2 semanas

    España Kenvue A tiempo completo

    Description Kenvue is currently recruiting for Regulatory Affairs intern Start Date : December 2024 Who we are At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including Neutrogena, Aveeno, Tylenol, Listerine, Johnson’s and BAND-AID® Brand...