Regulatory & Site Activation Specialist

Overview

• Liaise with SAR colleagues to drive plan, organize, compile, progress, track, and submit regulatory submissions on a timely basis and with a consistently high level of quality.
• May act as a contact point for translation review of submission documents such as applications, synopses, ICFs, labels, etc.
• Maintain country-specific patient information sheet and consent form customization text.
• Maintain country-specific drug labeling information and Country Intelligence Pages.
• Review and make recommendations on all relevant documentation (e.g., labels, patient information sheets, diary cards) to comply with ICH GCP and country-specific requirements.

Requirements

• A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or other related sciences.
• Minimum three years of experience in clinical research, preferably in site activation and/or regulatory-related function.
• Previous experience within the pharmaceutical/CRO industry.
• Thorough knowledge of ICH GCP, EU Clinical Trials Directive, and other relevant guidance on conducting clinical research.
• Experience in regulatory submissions in Australia.
• Multilingualism preferred; working knowledge of English.