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Job Details

Regulatory Affairs Associate - 1 year fixed term contract (renewable)

Company: PAREXEL
Location: Madrid, Madrid,Spain
Reference: 50152BR
Closing Date: 19 Feb 19
Type: Not Specified
Salary (£): Competitive
Benefits:

Job Summary:

PAREXEL values passion, global perspective and expertise and we are in the process of recruiting a Regulatory Affairs Associate to join our PAREXEL Consulting team in Madrid. PAREXEL Consulting offers services which create and maximize product value for clients throughout the product lifecycle, leveraging our unique fusion of scientific, regulatory, and business expertise. ...

Requirements:

PAREXEL values passion, global perspective and expertise and we are in the process of recruiting a Regulatory Affairs Associate to join our PAREXEL Consulting team in Madrid. PAREXEL Consulting offers services which create and maximize product value for clients throughout the product lifecycle, leveraging our unique fusion of scientific, regulatory, and business expertise. We are the pre-eminent regulatory and GxP (Good Clinical, Laboratory, or Manufacturing Practice) compliance consulting practice in the world.

Key accountabilities:

  • Preparing/supervising of submission of documents: Initial packages, substantial amendments and other notifications to regulatory authorities.
  • Filling out initial application forms.
  • Quality check of submission packages.
  • Preparing label designs for the investigational medicinal products.
  • Monitoring changes on the ongoing basis in EU legislation.
  • Advising on EU guidelines, EU requirements.
  • Acting in compliance with EU's pharmaceutical law, ICH-GCP, EU directives and in line with local and global procedures.
Qualifications
  • Degree in a Scientific or Technical Discipline.
  • Fluent in English and Spanish.
  • Excellent communication skills.
  • Previous experience in clinical trial submissions to MoH in Spain.
  • Nice to have: knowledge and/or previous experience in Marketing Authorization Applications.
  • Degree in a Scientific or Technical Discipline.
  • Fluent in English and Spanish.
  • Excellent communication skills.
  • Previous experience in clinical trial submissions to MoH in Spain.
  • Nice to have: knowledge and/or previous experience in Marketing Authorization Applications.

Apply for this job: Regulatory Affairs Associate - 1 year fixed term contract (renewable)

Contact Information:

Address:  PAREXEL International
The Quays
101-105 Oxford Road
Uxbridge
Middlesex
UB8 1LZ
England
Tel:  +44 1895 238000
Fax:  +44 1895 238494
Website:  Visit Our Web Site
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