(R266) | Specialist, Regulatory Affairs

hace 2 semanas


Madrid, España Worldwide Clinical Trials A tiempo completo

Requisition Number7568Employment Type : Regular

Who we are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe.

It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of almost 3,000 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

What you will do

- You will be a subject matter expert and local point of contact for activities supporting Regulatory submissions, site activation and maintenance for awarded projects.
- You will be responsible for planning, initiating and tracking documents required for regulatory submissions, essential documents collection, review and provision of country / site / EC requirements to support achievement of site activation goals and communicating status, risks and actions related to any start-up activities and maintenance when applicable.

What you will bring to the role

- Strong organizational and management skills. Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills.
- Self-motivated learning about current regulatory processes and intelligence
- Proactive by identifying potential issues in the process and anticipating solutions
- Thorough understanding of country level cultural norms and local healthcare systems; ability to initiate and develop relationships with local investigators and key site personnel

- Easily adjusts to a changing environment; ability to prioritize adapt between detailed and strategic activities while maintaining delivery timelines and quality
- Team-oriented work style; seeks and gives guidance to others

Your experience

- Degree with a major concentration in medical, biological, physical, health, pharmacy or other related science
- Minimum two year of experience in clinical research, in site activation and / or regulatory-related function within a CRO
- Candidates must have experience of the regulatory process in South Korea to be considered for this role.
- Good knowledge of ICH GCP, relevant clinical research conduct guidance and country regulations
- Multilingualism preferred; fluent in local language; working knowledge of English

Hace 13 horas

Escribe tu dirección de correo electrónico, te permitirá de estar al tanto de los últimos empleos por: (r266) | specialist, regulatory affairs - romania- home/office- based Escribe tu dirección de correo electrónico, te permitirá de estar al tanto de los últimos empleos por: (r266) | specialist, regulatory affairs - romania- home/office- based #J-18808-Ljbffr
  • Regulatory Affairs Specialist

    Encontrado en: Talent ES C2 - hace 1 semana


    Madrid, España Sealed Air Corporation A tiempo completo

    SEE designs and delivers packaging solutions that protect essential goods transported worldwide, preserve food, enable e-commerce and digital connectivity, and help create a global supply chain that is touchless, safer, less wasteful, and more resilient. Our people are entrepreneurial innovators and problem solvers committed to bringing unique insights and...

  • Regulatory Affairs Specialist

    Encontrado en: beBee S ES - hace 3 semanas


    Madrid, España Sealed Air Corporation A tiempo completo

    SEE designs and delivers packaging solutions that protect essential goods transported worldwide, preserve food, enable e-commerce and digital connectivity, and help create a global supply chain that is touchless, safer, less wasteful, and more resilient.   Our people are entrepreneurial innovators and problem solvers committed to bringing unique...


  • Madrid, España Kenvue A tiempo completo

    **Regulatory Affairs Intern**-2307004145W Description Cooperation with Commercial/Marketing teams. **Medicines Regulatory activities**: - New marketing authorization activities - Maintenance activities of existing licenses: preparations of administrative, quality regulatory packages and safety related variations for their submission to Healthcare...

  • Regulatory Specialist

    hace 2 semanas


    Madrid, España Sdi Digital Group A tiempo completo

    Diversey NL, for its offices in Utrecht, is looking for a : REGULATORY SPECIALIST The Senior Regulatory Specialist ensures legal compliance of Diversey's products in Italy, Malta, Greece and Cyprus. To this end, the person ensures a close collaboration and alignment of activities with the countries' leadership and trade associations in relevant countries and...


  • Madrid, España Adqualis A tiempo completo

    Importante Laboratorio Farmacéutico Chino de genéricos y biosimilares dentro de los Top 10 en su país; en pleno proceso de crecimiento y expansión en Europa precisa incorporar a un/a Regulatory Affairs Manager para su HQ Europeo en Madrid.En dependencia de la Dirección del Área se encargará principalmente de garantizar que los productos de la...

  • Regulatory Specialist

    hace 2 días


    Madrid, España Sdi Digital Group A tiempo completo

    Diversey NL, for its offices in Utrecht, is looking for a : REGULATORY SPECIALIST The Senior Regulatory Specialist ensures legal compliance of Diversey's products in Italy, Malta, Greece and Cyprus. To this end, the person ensures a close collaboration and alignment of activities with the countries' leadership and trade associations in relevant countries and...


  • Madrid, España MCR International A tiempo completo

    **CLM-2210-83** **REGULATORY AFFAIRS DIRECTOR** **MADRID** From MCR International, we are looking for a **Regulatory Affairs Director** for a well known Pharmaceutical company based in Madrid with the possibility of working remotely 50%. **Mission**: Define and implement the regulatory strategies to obtain marketing authorizations for the company's...


  • Madrid, España ABBVIE A tiempo completo

    **Overall responsibilities** To provide regulatory advice and support to the organization on the content of existing marketing authorizations and for products in development phase. Support pharmacovigilance department on safety relevant matters in line with national requirements **Main Accountabilities** - Obtain marketing authorizations for new...


  • Madrid, España Parexel A tiempo completo

    Madrid, Spain **Job ID** R0000013557 **Category** Regulatory / Consulting **ABOUT THIS ROLE**: We are recruiting for experienced Regulatory Affairs Professionals on various levels. In this role, you will focus on clinical trial submissions. We are looking for someone who is experienced in CTA, EU-CTR knowledge and experience would be a strong plus. The...


  • Madrid, España Ergomed A tiempo completo

    Company Description Ergomed PLC is a rapidly expanding full service mid-sized CRO specialising in Oncology and Rare Disease. Since its foundation in 1997 the company has grown organically and steadily by making strategic investments and landmark acquisitions, with operations in Europe, North America and Asia Our company allows for employee visibility (you...


  • Madrid, España NonStop Consulting A tiempo completo

    Tengo una nueva vacante como Regulatory Affairs Technician (solidos) para una importante empresa farmaceutica, el puesto es indefinido y hay muy buen ambiente laboral, ademas ofrecen muchas oportunidades de promocion. La vacante es office based con un dia de teletrabajo a la semana. **Responsibilities**: To stay updated on changes in legislation and...


  • Madrid, España Grupo Crit A tiempo completo

    **Descripción**: Desde Grupo Crit buscamos **un REGULATORY AFFAIRS MANAGER** en relación con nuevos productos, nuevos registros, nuevos territorios y proyectos de BD. para una empresa dedicada al suministro de productos farmacéuticos genéricos sobre todo para hospitales ubicada en Alcobendas. **FUNCIONES**: - Será la persona responsable de la...

  • Regulatory Manager

    hace 13 horas


    Madrid, España Precision For Medicine A tiempo completo

    Precision for Medicine (CRO) are recruiting a Regulatory Manager to join our team, candidates can be based in the following countries: UK, Spain, Hungary, Slovakia, Serbia, Romania or Poland. Position Summary: The Regulatory Manager (RM) provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings,...

  • Regulatory Manager

    hace 3 días


    Madrid, España INSUD PHARMA, S.L.U. A tiempo completo

    Overview: **General Responsibility** The Manager, Regulatory Affairs CMC is responsible for defining and implementing global CMC strategies including regulatory relevant technical guidance to development teams and ensures adequacy of CMC documentation for global regulatory submissions. The position supports and promotes all regulatory CMC tasks throughout...

  • Regulatory Affairs Manager

    Encontrado en: Talent ES C2 - hace 1 semana


    Madrid, España IQVIA A tiempo completo

    The Manager, Regulatory Affairs International supports ambitious geographical expansion plans. The position will support registration of existing portfolio products into new territories and to register several of development projects into the international region. This role is key to driving both the Regulatory strategy and execution.• Provide...


  • Madrid, España Oxford Global Resources A tiempo completo

    Location: Madrid, Spain - Contact: Susagna Sastre Magem - Job type: Permanent - Contact phone: +34 935 222 338 - Industry: Pharmaceutical, Life Sciences, Biotechnology Oxford Global Resources en colaboración con Laboratorio Farmacéutico Español con fabricación y presencia y distribución internacional busca un Regulatory Affairs Officer para sus...

  • Qa Ra

    hace 1 semana


    Madrid, España Mcr International A tiempo completo

    LAR-2403-94 QA RA & PV SPECIALIST MADRID From MCR International, we are actively seeking a Quality Assurance, Regulatory Affairs, and Pharmacovigilance Specialist & Technical Responsible Deputy in Madrid for a leading pharmaceutical company. Functions: Support in the maintenance of the Quality Management System. Ensure the correct functioning of the...


  • Madrid, España AstraZeneca A tiempo completo

    En AstraZeneca convertimos las ideas en medicamentos que cambian vidas. Trabajar aquí significa ser emprendedor, pensar en grande y trabajar juntos para hacer realidad lo imposible. Cada decisión que tomamos está basada en las posibilidades que la ciencia nos ofrece. Desde nuestros laboratorios hasta los departamentos de ventas o marketing, el equipo de...

  • Regulatory Manager

    Encontrado en: Talent ES C2 - hace 1 semana


    Madrid, España Parexel A tiempo completo

    When our values align, there's no limit to what we can achieve.   Are you an experienced regulatory professional looking for a new opportunity? We are currently seeking a talented CMC Regulatory Manager (Regulatory Affairs Consultant) to join our dynamic team! This is a client dedicated project, and the role can be office or home based in various...

  • Regulatory Affairs Officer Trainee

    Encontrado en: Talent ES C2 - hace 1 semana


    Madrid, España Viatris A tiempo completo

    Viatris Pharmaceuticals S.L. At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access – Providing high quality trusted medicines...