Regulatory Affairs Professional

hace 2 semanas


Madrid, España Parexel A tiempo completo

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 role can be based in our office in Madrid or remote.

**Key Deliverables in the role**:

- Manage the local submissions (as Local Regulatory Contact - LRC) but should also be able to coordinate the regulatory submissions in all participating countries as Regulatory Lead.
- Regulatory submission of Clinical Trial in Spain according to EU-CT directive but also via EU-CTR process (experience in this field would be appreciated).
- Participate in Regulatory Operations meetings, project team meetings, and maintain relationships with other departments, clients, and regulatory agencies as necessary.
- You may be involved in local, regional, and/or global projects

**You will need**:

- Educated to at least Bachelor of Science level or Bachelor of Science
- Relevant clinical research experience in regulatory affairs and management of international clinical trials
- Extensive prioritization skills; must be able to resolve conflicting priorities to meet tight deadlines while maintaining quality and attention to details
- Ability to work with a multinational team, focusing on multiple issues under tight timelines
- Creative problem-solving skills, which supports client-focused approach to work
- Fluent in written and spoken English


  • Sr Regulatory Affairs

    hace 4 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...


  • Madrid, 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...

  • Sr Regulatory Affairs New

    hace 4 semanas


    Madrid, España Oxford Global Resources A tiempo completo

    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...


  • Madrid, España ENI A tiempo completo

    OPEN DATE-CLOSING DATE: 23/02/2024-08/04/2024 European Union-Spain-MADRID-ES-MADRID GLORIETA DE QUEVEDO PROFESSIONAL FAMILY: LEGAL AFFAIRS Home National | Expert | Residential **IRC225222 - PUBLIC AFFAIRS AND REGULATORY MANAGER** At **Eni**, we are looking for a **Public Affairs and Regulatory Manager** within** Plenitude Renewables** in **Madrid,...


  • Madrid, España Morgan Philips Executive Search A tiempo completo

    **Global responsibility**: Provide regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ensuring timely preparation of well organized, quality regulatory submissions in compliance with applicable regulations. Coordinates and...


  • 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 Blu Selection A tiempo completo

    Our client is looking for a dynamic and experienced Manager of Regulatory Affairs and Compliance to oversee the Regulatory Affairs functions for the EMEA and APAC regions. **Your Responsibilities and Impact as Regulatory Affairs Manager will be**: - Supervising Regulatory Affairs for EMEA and APAC jurisdictions, ensuring adherence to procedures and...


  • Madrid, Madrid, España Johnson & Johnson A tiempo completo

    Johnson & Johnson is currently seeking a Regulatory Affairs intern to join our Regulatory Affairs department located in Madrid. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive,...


  • Madrid, España PrimeVigilance A tiempo completo

    Company Description We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs...


  • Madrid, España NonStop Consulting A tiempo completo

    Tengo una nueva vacante como Regulatory Affairs Technician para trabajar en CMC 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 y el horario es flexible. **Responsabilidades**: Mantenerse...

  • Regulatory Affairs

    hace 3 días


    Madrid, España Manpower A tiempo completo

    Desde Manpower buscamos Regulatory Affairs (H/M/X) Si tienes experiencia como Regulatory Affairs, Esta es tu oportunidad ¡Inscríbete! Funciones: - Garantiza que todas las actividades relacionadas con el registro de nuevos productos y su mantenimiento en el mercado español cumplen con la Normativa HA española. - Gestiona las actividades regulatorias...

  • Regulatory Affairs

    hace 4 días


    Madrid, España Sin especificar A tiempo completo

    Desde Manpower buscamos Regulatory Affairs (H/M/X)Si tienes experiencia como Regulatory Affairs, Esta es tu oportunidad ¡Inscríbete!Funciones:- Garantiza que todas las actividades relacionadas con el registro de nuevos productos y su mantenimiento en el mercado español cumplen con la Normativa HA española.- Gestiona las actividades regulatorias para...

  • Regulatory Affairs

    hace 4 días


    MADRID, España Manpower España A tiempo completo

    Desde Manpower buscamos Regulatory Affairs (H/M/X) Si tienes experiencia como Regulatory Affairs, Esta es tu oportunidad ¡Inscríbete! Funciones: - Garantiza que todas las actividades relacionadas con el registro de nuevos productos y su mantenimiento en el mercado español cumplen con la Normativa HA española. - Gestiona las actividades regulatorias...


  • Madrid, España Statkraft A tiempo completo

    Public Affairs and Regulatory Manager Spain - Full-time **Company Description**: Statkraft has been making clean energy possible for over a century. Today, we are Europe’s largest renewable energy producer and a global energy market operator. We are a vibrant, diverse and strongly connected community of over 4800 people, working across 19 countries within...

  • Regulatory Manager

    hace 2 semanas


    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,...


  • Madrid, España Page Personnel España A tiempo completo

    Asegurarse de que la información esencial del expediente tras su aprobación se comparte con los departamentos implicados de acuerdo con los procedimientos pertinentes. - Compilar y preparar la documentación necesaria para la presentación de modificaciones y variaciones. - Seguimiento de cambios regulatorios y análisis de impacto en fórmulas...

  • Regulatory Lead

    hace 4 semanas


    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 SPRIM GLOBAL PARTNERS SL A tiempo completo

    SPRIM is searching for a Scientific Affairs Business Development Consultant to support our growing medical excellence, medical Innovation and regulatory affairs department called the “Scientific Excellence Platform”. In this role you will focus on B2B marketing and sales activities to sell SPRIM services to Global Healthcare, Pharma, Biotech, Med Tech...


  • 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...