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Junior Regulatory Affairs Officer (R1065332) in Madrid, ES at IQVIA™

Date Posted: 2/12/2019

Job Snapshot

  • Employee Type:
    JTNS
  • Location:
    Madrid, ES
  • Experience:
    Not Specified
  • Date Posted:
    2/12/2019
  • Job ID:
    R1065332

Job Description

Join us on our exciting journey! IQVIA™ is The Human Data Science Company™, focused on using data and science to help healthcare clients find better solutions for their patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness advances in healthcare information, technology, analytics and human ingenuity to drive healthcare forward.

PURPOSE
Prepare and review regulatory submissions to support marketing authorisation activities for either internal and/or external clients. Provides regulatory support for assigned projects.

RESPONSIBILITIES

  • Elaborate and / or give support in the preparation of the technical documents of the applications for registration of new products, line extensions, revalidations, cancellations, etc. In accordance with applicable regulations, current legislation and company procedures.
  • Collaborate in the management and review of the conditioning material of the company's products in accordance with applicable regulations, current legislation and company procedures.
  • Collaborate in the submission of applications, modifications and notifications of Clinical Trials to the Health Authorities (AEMPS) and in the follow-up until the authorization of the same, in accordance with applicable regulations, current legislation and company procedures.
  • Collaborate with the Department of Technical Management in the communication of changes in marketing authorizations that affect: manufacturers, specifications, labeling, patient leaflet and approvals of new registrations, cancellations and transfers of our medicines.
  • Collaborate in the maintenance and updating of the databases of records and archives.
  • Collaborate in the management of communications and telematics shipment with the Health Authorities through RAEFAR or other applications. 

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

  • Graduate in Pharmacy or Health Sciences degree
  • 1 year experience in Regulatory Affairs activities
  • Fluent in English and Spanish

We know that meaningful results require not only the right approach but also the right people. Regardless of your role, we invite you to reimagine healthcare with us. You will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes. Whatever your career goals, we are here to ensure you get there! We invite you to join IQVIA™



Job ID: R1065332