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Regulatory Compliance Officer

2 weeks ago

Centurion, Gauteng, South Africa IQVIA Argentina Full time

Role Overview

The Regulatory Compliance Officer will be responsible for ensuring that all regulatory activities are executed in accordance with regulatory requirements. This includes overseeing the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU site activation strategy, adhering to project timelines.

Responsibilities:

  • Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
  • Identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the site activation plan.
  • Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis, and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.

Requirements:

  • Bachelor's Degree in Life sciences or related field.
  • 7 years' relevant experience in a scientific or clinical environment, including demonstrable experience in an international role.
  • Good understanding of regulated clinical trial environment and in-depth knowledge of drug development process.