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Senior Regulatory Affairs Specialist (Home based/ Europe) - Novella Clinical (R1041745) (R1050643) in Stevenage, UK at IQVIA™

Date Posted: 1/9/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Stevenage, UK
  • Experience:
    Not Specified
  • Date Posted:
    1/9/2019
  • Job ID:
    R1050643

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.

  • Working knowledge of and aptitude for activities related to regulatory affairs and quality assurance, both domestic and international.
  • Experience interacting with regulatory agencies is preferred.
  • Ability to understand and communicate regulatory requirements for different therapeutic areas and countries and associated submission pathways.
  • Familiarity with or ability to become familiar with regulatory documents, general contents, organization and the methods of filing and tracking.
  • Familiarity with or ability to become familiar with principles of Good Clinical Practice, Good Laboratory Practice and Good Manufacturing Practice., ISO standards.
  • Extensive knowledge of clinical research; knowledge and familiarity with 21CFR11 and EDC systems.
  • Experience in preparation of audit plans and checklists against applicable standards, execution of audits, and preparation of comprehensive written audit reports.
  • Good interpersonal skills with the ability to communicate effectively, both orally and in writing, with all levels of staff, and with the public. 
  • Ability to be detail oriented with background adequate to deal with scientific issues related to technical regulations and SOPs.
  • Ability to read and synthesize technical material and to prepare clear and concise written documents.

Computer literate at a level allowing utilization of event tracking programs, data loading and information processing related to regulatory affairs and quality assurance

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: R1050643