Regulatory Affairs Officer, IQVIA Biotech

Key Responsibilities

• Serve as Regulatory Team Lead on complex global studies, including oversight of technical writing and submission publishing.
• Draft, review, and quality-check clinical trial regulatory core study documentation at global and country level.
• Engage directly with clients to clarify clinical trial regulatory pathways, share lessons learned, and address feedback.
• Engage with Competent Authorities in countries across multiple regions, as part of the clinical trial regulatory strategy for complex global studies
• Monitor scope, deliverables, timelines, and budget; proactively mitigate risks and elevate issues as needed.
• Provide guidance and feedback to junior colleagues; support training and continuous improvement initiatives.
• Contribute to internal SOP reviews and present regulatory processes at full-service bid defenses.
• Perform additional tasks assigned by Regulatory management to m...