Regulatory & Site Activation Specialist

This is a fully remote position, open to applicants in Australia.

📋 Description

• Collaborate with SAR team members to efficiently plan, organize, compile, track, and submit regulatory submissions punctually, ensuring a consistently high standard of quality.

• Serve as a point of contact for the review of translations related to submission documents such as applications, synopses, informed consent forms (ICFs), labels, etc.

• Update and maintain country-specific patient information sheets and customization text for consent forms.

• Keep up-to-date country-specific drug labeling information and Country Intelligence Pages.

• Assess and provide recommendations on all pertinent documentation, such as labels, patient information sheets, and diary cards, to ensure compliance with ICH GCP and country-specific regulations.

⛳️ Requirements

• A minimum of a four-year college degree with a major in medical, biological, physical, health, pharmacy, or other related sciences.

• At least three years of experience in clinical research, ideally in site activation and/or regulatory functions.

• Prior experience in the pharmaceutical or CRO industry is essential.

• Comprehensive understanding of ICH GCP, EU Clinical Trials Directive, and other relevant guidelines for conducting clinical research.

• Experience with regulatory submissions in Australia is required.

• Multilingual candidates are preferred; a working knowledge of English is necessary.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Flexible work hours

• Paid time off

• Remote work options