Regulatory Affairs Associate

hace 1 semana

barcelona, España JR Spain A tiempo completo

Social network you want to login/join with: Company Overview With a unique legacy in dermatology and decades of innovation, Galderma is a leading dermatology company, present in approximately 90 countries. We offer an innovative, science-based portfolio of premium brands and services across Injectable Aesthetics, Dermo-cosmetics, and Therapeutic Dermatology. Founded in 1981, our focus is on the human body's largest organ - the skin - aiming to meet individual needs with superior outcomes in partnership with healthcare professionals. We seek individuals focused on results, eager to learn, and positive. Our team values initiative, teamwork, and collaboration, with a passion for making a meaningful impact for consumers, patients, and healthcare professionals. We promote personal growth, diversity, and respect for privacy and dignity across our organization. Global Capability Center We are establishing a new Global Capability Center in Barcelona, located in the Eixample District, to support our global teams. This center offers opportunities for professional development through exposure to international projects and global career paths. Job Title: Specialist, Regulatory Affairs Strategy Location: Barcelona, Spain (hybrid) Job Description Developing and managing clinical trial regulatory strategies for biologics, ensuring alignment with timelines and responding to health authority queries. Overseeing clinical trial regulatory submissions and ensuring compliance. Archiving clinical trial documentation. Managing interactions with health authorities in designated regions. Assessing risks related to regulatory submissions and proposing mitigation strategies. Providing updates to global regulatory teams. Managing external vendors. Skills & Qualifications Knowledge of regulatory requirements for pharmaceutical/biological products. Experience with regulatory submissions in key regions. Ability to communicate strategies and issues effectively to senior leadership. Experience working with regulatory agencies and implementing strategies. Strong team interaction skills and adaptability to change. What We Offer A diverse and inclusive work environment. Competitive salary, bonus, and benefits. Hybrid work culture. Personalized career development opportunities. Ownership and accountability from day one. Next Steps Initial virtual interview with a recruiter. Follow-up virtual interview with the hiring manager. Panel interview with the extended team. Our people make a difference. Join us to work with diverse, talented individuals who bring unique perspectives and expertise. #J-18808-Ljbffr

  • Regulatory Affairs Associate

    hace 4 días

    Barcelona, Barcelona, España Inter Regulatory A tiempo completo

    Regulatory Affairs Associate (Medicines)Location:Barcelona, Spain (Hybrid – Barcelona Health Hub)Company:Inter RegulatoryEmployment Type:Full-timeAbout the roleInter Regulatory is expanding its European Regulatory Affairs team and is seeking aRegulatory Affairs Associate (Medicines)to join our consultancy based inBarcelona, primarily working from...

  • Regulatory Affairs Associate

    hace 11 horas

    Barcelona, España Inter Regulatory A tiempo completo

    Regulatory Affairs Associate (Medicines) Company: Inter RegulatoryEmployment Type: Full-timeAbout the role Inter Regulatory is expanding its European Regulatory Affairs team and is seeking a Regulatory Affairs Associate (Medicines) to join our consultancy based in Barcelona , primarily working from the Barcelona Health Hub .This role is suited to a...

  • Regulatory Affairs Associate

    hace 11 horas

    Barcelona, España Inter Regulatory A tiempo completo

    A growing regulatory consultancy in Barcelona is seeking a Regulatory Affairs Associate with 3-5 years of experience in pharmaceutical Regulatory Affairs. The role involves authoring and managing regulatory dossiers, handling CMC documentation, and supporting US regulatory applications. Candidates should have a scientific degree and be fluent in English and...

  • Cmc Regulatory Affairs Associate Director

    hace 1 semana

    Barcelona, España AstraZeneca A tiempo completo

    **Location: Barcelona, Spain (we requiere 3 days working from the office and 2 days working from home** Our **Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs** function delivers expert CMC regulatory input for projects spanning across the product lifecycle and leads the regulatory strategy for the development, manufacturing and testing of...

  • Regulatory Affairs Associate Director

    hace 3 días

    Barcelona, España AstraZeneca A tiempo completo

    Welcome to AstraZeneca, where we prioritize patients and strive to meet their needs globally. We are a team of entrepreneurial thinkers, big dreamers, and collaborators who work together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of...

  • Regulatory Affairs

    hace 3 días

    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...

  • Trainee Regulatory Affairs

    hace 2 semanas

    Barcelona, España HARTMANN A tiempo completo

    En HARTMANN nos dedicamos a **ayudar**, **cuidar**, **proteger** y **crecer**. Apoyamos a los profesionales de la salud para que puedan concentrarse en lo que realmente importa: impactar positivamente en la vida de las personas. Creamos soluciones que marcan la diferencia, y con tu compromiso podrás desarrollarte profesionalmente cada día. En HARTMANN tu...

  • Senior Associate Regulatory Affairs

    hace 1 semana

    Barcelona, España Amgen A tiempo completo

    **HOW MIGHT YOU DEFY IMAGINATION?** If you feel like you’re part of something bigger, it’s because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering...

  • Regulatory Affairs Junior

    hace 2 semanas

    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,...

  • Regulatory Affairs Director

    hace 5 días

    Barcelona, España Consult Search A tiempo completo

    **Scope**: Director of regulatory affairs position that has been opened to further accompany the growth of the company on this sector. Although our client is a historically pharma oriented manufacturer, they have in the recent years expanded their activities in the Medical Aesthetics area, with products currently on market in the Dermal and Hyaluronic acid...