Detalles del puesto

Senior Regulatory Affairs Associate (2-years-contractor)

Madrid   •  Temporary   •  Publicado 06/07/16

Bullet points

  • Two-years Contractor
  • Senior role for the Regulatory Affairs Department

Acerca de nuestro cliente

One of the most important Companies in the Health-care industry in the world, probably the most influencing and relevant currently according to its portfolio and the way these products improve people's life.

Descripción de la oferta

  • To prepare and maintain regulatory applications including variations in line with local and EU requirements.
  • Preparation and contribution to submissions and maintenance of marketing authorizations and license renewals.
  • Review promotional and non-promotional activities and materials ensuring their compliance with local guidance, codes of conduct, and SOP's.
  • Review and approval of packaging materials in line with approved licenses.
  • Responsible for submissions which may include safety reports, amendments, supplements to clinical trial applications.
  • Responsible for preparing regulatory submissions in line with ICH requirements, Clinical Trials Directive, and local requirements and scientific and Company policies.

Perfil buscado (h/m)

  • Degree in biological/life sciences or pharmacy or medicine.
  • Relevant experience in Regulatory Affairs.
  • Experience in preparing and submitting regulatory documents to support the Company's products life cycle and clinical trials.
  • Very good understanding of European regulations relating to clinical trials.
  • Fluent in English and excellent verbal and written communication skills.
  • Outstanding organizational skills and ability to work on deadlines-based projects.

Qué Ofrecemos

Opportunity to work in one of the most important Companies in the world, mainly in the Health-care industry.

Me interesa este trabajo

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