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Regulatory Affairs Associate (Italy, Home-Based) - IQVIA Biotech

Employer
IQVIA Biotech
Location
Italy (IT)
Salary
Competitive
Start date
14 Feb 2019
Closing date
7 Mar 2019

Job Details

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.

Here at IQVIA Biotech we have a vacancy within our Regulatory Team for an experienced Regulatory Associate based in Italy.

Your role will involve:

To provide regulatory and quality support to select clinical research projects involving investigational or marketed drugs, devices, biologics, or new medical procedures. Work with the Manager of Regulatory Affairs to provide strategic regulatory guidance and information to projects; to acquire pertinent regulatory information from agencies and organisations; to support regulatory agency interactions, communications, and submissions; and to review project regulatory documentation to ensure compliance with applicable regulatory regulations and guidelines.

Duties to Include:

  • Assist Manager, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing to the project team regulatory information, guidance, training, support and strategic planning based on applicable regulations and guidances issued by the applicable regulatory agency(ies).
  • Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organisations.
  • Review protocols, consent forms, reports, scientific documents, publications, and related papers, etc., as appropriate for various clinical research projects to ensure compliance with regulations.
  • Ensure the compilation and maintenance of pertinent documentation (e.g., files) required for regulatory compliance for assigned clinical research projects. 
  • Serve as a member of groups, teams, or committees related to regulatory affairs, and quality assurance or other designated Novella activities, as appropriate.
  • Serve as Novella liaison with central IRBs.
  • Perform other related duties as assigned.

Please apply by following the link to our website. 

 

Company

IQVIA Biotech is the global, enterprise-wide solution that provides flexible, tailored, integrated clinical and commercial solutions to small biotech and pharmaceutical companies, from planning through trial design and implementation to launch and commercialization.

We recognize that the needs of small companies are different than large companies, so we developed a separate business unit within IQVIA which provides a high-touch solution with high levels of service and hands-on attention, with the benefits of IQVIA’s data and expertise – including powerful analytics, resources, therapeutic experts and global footprint.

IQVIA Biotech has five therapeutic divisions. Complementing our successful history in Oncology, we have dedicated delivery teams in General Medicine – which includes Dermatology, Cardiovascular/Renal/Metabolics, Central Nervous System and Immunology.

Interested in being a part of this exciting and dynamic team?

Contact us today to find out more!

 

Company info
Website
Telephone
+44(0)1438 221122
Location
Ground Floor
Abel Smith House
Gunnells Wood Road
Stevenage
Herts
SG1 2ST
United Kingdom

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