Clinical Trials Regulatory Manager

2 months ago


Ar Rayyan, Baladīyat ar Rayyān, Qatar IQVIA Full time
Regulatory Affairs Specialist

This is a Full Remote job, the offer is available from various locations. As a Regulatory Affairs Specialist at IQVIA, you will be responsible for preparing and reviewing regulatory documents to support clinical trial submissions. You will also provide regulatory support for more complex projects.

Responsibilities:
  • Act as a Clinical Trial Regulatory Manager on global projects, which may be complex.
  • Review and provide feedback on core scientific documentation and gap analysis to customers.
  • Prepare and maintain core clinical trial submission dossiers in accordance with applicable regulatory requirements.
  • Write scientific documents, such as Investigational Medicinal Product Dossiers and clinical trial justifications, with minimal support from senior staff.
  • Plan and perform European centralized submissions and facilitate global submissions.
  • Support regulatory business development opportunities and complete Data Informed Protocol Assessments (DIPAs).
  • Understand the Scope of Work, deliverables, and budget for any given project and ensure timelines are met.
  • Maintain accurate completion, maintenance, and adherence to internal systems, databases, tracking tools, and project plans in line with agreed SOPs.
  • Deliver regulatory training and presentations as required.

This role requires a strong understanding of regulatory requirements and the ability to work independently. If you have experience in clinical trials and regulatory affairs, we encourage you to apply.



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