Sr Regulatory Affairs

hace 2 semanas


Madrid, España Oxford Global Resources A tiempo completo

**Sr Regulatory Affairs**:

- Location:
Madrid, Spain
- Contact:
Susagna Sastre Magem
- Job type:
Temp to Perm
- Industry:
Pharmaceutical, Life Sciences, Biotechnology

Oxford Global Resources ETT is looking to hire a **Regulatory Affairs Specialist (maternity leave) who will start in August 2023**. As a Regulatory Affairs Technician you will support a top leading research-based bio pharmaceutical company focused on the discovery, development, and commercialization of innovative medicines.

**Responsibilities**:

- ** Review promotional and non-promotional materials in accordance with the company internal promotional guidelines, national regulations and Codes of Practice. Provision of guidance and assistance to Marketing during preparation of promotional material.**:

- Cross functional interactions with Business Unit, Medical and other departments if required. Provision of regulatory advice as appropriate
- Translation of Regulatory documents. Submission and follow-up of regulatory submissions to national authority as well as the amendments to product information as required by acting as a Liaison with Int RA for these activities.
- ** Submission of clinical trials amendments and notifications to competent authorities of the clinical trials under his/her responsibility**:

- ** Regulatory Intelligence: Competitors, new regulations or other relevant information**:

- Quality topics: Knowledge of applicable regulations. Preparation and update of Quality SOPs, management of complaints and other quality topics.
- Creation and update of SOPs and associated process documentation as required.

**Education**
- Bachelor's degree (or equivalent) in a scientific discipline.
- Minimum of 2-3 years (in CRO or Pharma) working in Spain regulatory affairs is required
- Experience in initial CTA is essential
- Hands-on experience preparing, reviewing, and submitting regulatory documentations

**Benefits**
- Interim/temporary contract maternity leave
- Ticket Restaurant
- Medical Insurance
- Hybrid 60% home-based



  • 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...


  • 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...

  • 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...


  • 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...

  • 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 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 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...

  • Regulatory Manager

    hace 1 día


    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...

  • 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...

  • Regulatory Specialist

    hace 14 horas


    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...

  • Regulatory Lead

    hace 6 días


    Madrid, España BAXTER A tiempo completo

    **This is where you save and sustain lives** At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...


  • Madrid, España Moderna A tiempo completo

    **The Role**: Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners...


  • Madrid, España Pfizer A tiempo completo

    Role purpose: The role of the Senior Policy and Public Affairs Manager is critical to the successful delivery of the Policy and Public Affairs strategy and to delivering breakthroughs that change patients’ lives in [country]. A strategic, externally facing role, encompassing a wide range of stakeholder engagement responsibility and requiring a high degree...

  • 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...

  • Becario Medical Affairs

    Encontrado en: beBee jobs ES - hace 2 semanas


    Madrid, Madrid, España Organon A tiempo completo

    Job Requirements Tus tareas:Colaboración/participación en la ejecución de la estrategia médico/científica del departamento Médico de España, como, por ejemplo:Organización y seguimiento de programas de educación médica continuada.Planificación y desarrollo de materiales promocionales y campañas educacionales, incluyendo la revisión del contenido...


  • Madrid, España Iata Consulting A tiempo completo

    Senior Manager External Affairs and Sustainability Employment Type: Permanent Contract Duration:  At IATA, we speak for the airlines of theworld, serving and supporting over 300 of them across all continents. Weare passionate and knowledgeable about the aviation industry, and we strive tomake it safer, smarter, more sustainable and more inclusive. We...


  • Madrid, España NonStop Consulting A tiempo completo

    I am actively seeking an experienced RA professional with excellent communication skills and a business mind-set who will provided value-added input to internal stakeholders and clients for a medium-sized pharmaceutical company located in Basel that is growing rapidly. In this exciting and challenging position you will take full responsibility for your...