Regulatory Affairs Officer, Spain

hace 24 horas

Majadahonda Madrid provincia, España Linical Europe A tiempo completo

Linical Co., Ltd. (‘Linical’) is a premier global CRO headquartered in Osaka, Japan, listed in the prime segment of the Tokyo Stock exchange, and dedicated to serve its clients as a true partner in development. With approximately 900 employees Linical directly covers a total of more than 20 countries in Europe, North America and Asia-Pacific including Japan via its own offices and staff.

Linical’s European arm is headquartered in Frankfurt, Germany with a substantial presence in Paris and Madrid. Its geographic footprint facilitates a significant presence in the leading Western European markets, combined with well-established affiliate operations in key emerging markets in Central
- and Eastern Europe.

**As a Regulatory Affairs Officer (RAO), you will be responsible for**:

- Ensure completeness and accuracy of the CA/IRB/IEC submission packages, with the assistance of the CRA in charge of the country/site.
- Ensure deadlines are met for submissions.
- Act as liaison with regulatory agencies to request information and resolve any questions or issues, as and when required/requested by the Project Management, Regulatory Affairs Manager, or client.
- Provide ongoing support to project teams for regulatory issues, including preparation of required forms for amendments and study end notification
- Collaborate with the Quality Assurance team and the Regulatory Affairs Manager to maintain, develop and review regulatory SOPs and relevant attachments. Support the training of local Linical office personnel such as CRAs on relevant regulatory processes.
- Perform all RAO’s tasks specified in SOPs for the local office location, or delegate such tasks to suitably trained personnel.
- Contact for Regulatory Affairs Manager, Project Manager, Quality Assurance Department and Training Department of Linical.
- Reporting to the client(s) as and when required and specified in project communication plan, and/or agreement with the Project Manager.
**Experience required**:

- Experience working at a CRO or Pharmaceutical company
- At least 3 years (comprehensive) practical working experience in Regulatory Affairs.
- Advanced knowledge in the conduct of clinical trials and the corresponding regulatory requirements/ procedures desired in Spain
- At least a basic understanding of US- FDA regulations would be a plus.
- Fundamental knowledge in European regulations, ICH GCP and any further applicable regulatory requirements and legislation
- Excellent professional use of local and English language (written and spoken) and good communication skills.
- Work precisely according to procedures, rules, and regulations.
- Problem-solving ability and strong team player.
- Careful planning to achieve accurate and timely results.
**Education and Qualifications**:

- University degree (e.g., PhD or Master), scientific background (e.g.

Medicine, Chemistry, Biochemistry, Biology, Pharmacology, Pharmacy or

equivalent related area or education as medical documentalist, nurse,

medical / pharmaceutical / biological technical assistant, doctor’s assistant,

or other profession if experience beyond four years within clinical research

  • Regulatory Affairs Officer

    hace 4 semanas

    Madrid, España Inmunotek A tiempo completo

    Si te apasiona la industria farmacéutica y cuentas con experiencia como Regulatory Affairs, ¡esta es tu oportunidad!En Inmunotek estamos creciendo y por ello necesitamos incorporar a nuestro departamento de Regulatory Affairs un/a Regulatory Affairs Officer en nuestra planta de Alcalá de Henares.Te encargarás de: Preparar, revisar y presentar la...

  • Regulatory Affairs Officer

    hace 3 semanas

    Madrid, España Inmunotek A tiempo completo

    Si te apasiona la industria farmacéutica y cuentas con experiencia como Regulatory Affairs, ¡esta es tu oportunidad!En Inmunotek estamos creciendo y por ello necesitamos incorporar a nuestro departamento de Regulatory Affairs un/a Regulatory Affairs Officer en nuestra planta de Alcalá de Henares.Te encargarás de: Preparar, revisar y presentar la...

  • Regulatory Affairs Officer

    hace 5 días

    Madrid, España Inmunotek A tiempo completo

    Si te apasiona la industria farmacéutica y cuentas con experiencia como Regulatory Affairs, ¡esta es tu oportunidad!En Inmunotek estamos creciendo y por ello necesitamos incorporar a nuestro departamento de Regulatory Affairs un/a Regulatory Affairs Officer en nuestra planta de Alcalá de Henares.Te encargarás de: Preparar, revisar y presentar la...

  • Regulatory Affairs Officer

    hace 3 semanas

    Madrid, España Inmunotek A tiempo completo

    Si te apasiona la industria farmacéutica y cuentas con experiencia como Regulatory Affairs, ¡esta es tu oportunidad!En Inmunotek estamos creciendo y por ello necesitamos incorporar a nuestro departamento de Regulatory Affairs un/a Regulatory Affairs Officer en nuestra planta de Alcalá de Henares.Te encargarás de: Preparar, revisar y presentar la...

  • Regulatory Affairs Officer

    hace 3 semanas

    Madrid, España Inmunotek A tiempo completo

    Si te apasiona la industria farmacéutica y cuentas con experiencia como Regulatory Affairs, ¡esta es tu oportunidad! En Inmunotek estamos creciendo y por ello necesitamos incorporar a nuestro departamento de Regulatory Affairs un/a Regulatory Affairs Officer en nuestra planta de Alcalá de Henares. Te encargarás de: - Preparar, revisar y presentar la...

  • Regulatory Affairs Officer

    hace 2 semanas

    Madrid, España Inmunotek A tiempo completo

    Si te apasiona la industria farmacéutica y cuentas con experiencia como Regulatory Affairs, ¡esta es tu oportunidad!En Inmunotek estamos creciendo y por ello necesitamos incorporar a nuestro departamento de Regulatory Affairs un/a Regulatory Affairs Officer en nuestra planta de Alcalá de Henares.Te encargarás de:- Preparar, revisar y presentar la...

  • Regulatory Affairs Officer

    hace 4 días

    Madrid, España Inmunotek A tiempo completo

    Si te apasiona la industria farmacéutica y cuentas con experiencia como Regulatory Affairs, ¡esta es tu oportunidad! En Inmunotek estamos creciendo y por ello necesitamos incorporar a nuestro departamento de Regulatory Affairs un/a Regulatory Affairs Officer en nuestra planta de Alcalá de Henares. Te encargarás de: Preparar, revisar y presentar la...

  • Regulatory Affairs Officer

    hace 2 días

    Madrid, España Inmunotek A tiempo completo

    Si te apasiona la industria farmacéutica y cuentas con experiencia como Regulatory Affairs, ¡esta es tu oportunidad! En Inmunotek estamos creciendo y por ello necesitamos incorporar a nuestro departamento de Regulatory Affairs un/a Regulatory Affairs Officer en nuestra planta de Alcalá de Henares. Te encargarás de: Preparar, revisar y presentar la...

  • Regulatory Affairs Specialist — Spain

    hace 2 semanas

    madrid, España IQVIA A tiempo completo

    A leading healthcare data company is seeking a Regulatory Affairs Specialist to support post-approval regulatory activities for human medicinal products in Spain. This role requires at least 4 years of experience in regulatory affairs and proficiency in English and Spanish. Responsibilities include preparing regulatory documents, ensuring compliance with...

  • Fdf Regulatory Affairs Officer

    hace 4 días

    08130 Santa Perpètua de Mogoda, Barcelona provincia, España GENUINE A tiempo completo

    **FDF REGULATORY AFFAIRS OFFICER** Nuestro cliente es una compañía farmacéutica española cuyo negocio está centrado en I+D, licencia, fabricación y suministro de productos farmacéuticos. Cuenta con un amplio conocimiento y experiência en ofrecer productos y soluciones de calidad en el ecosistema de la salud. Sus valores abanderan un alto compromiso...