Regulatory & Site Activation Specialist

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

📋 Description

• Collaborate with SAR team members to plan, organize, compile, monitor, track, and submit regulatory documents in a timely manner while ensuring a consistently high standard of quality.

• May serve as a point of contact for reviewing translations of submission materials such as applications, synopses, informed consent forms (ICFs), labels, and more.

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

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

• Evaluate and provide recommendations on all pertinent documentation, including 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 focus in medical, biological, physical, health, pharmacy, or other related fields.

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

• Prior experience within the pharmaceutical or CRO industry.

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

• Experience with regulatory submissions in Australia.

• Multilingual skills are preferred; proficiency in English is required.

🏝️ Benefits

• Competitive salary

• Flexible working hours

• Professional development budget

• Home office setup allowance

• Global team events