Specialist, Regulatory & Site Activation

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

📋 Description

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

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

• Maintain and customize country-specific patient information sheets and consent forms, as well as manage country-specific drug labeling information and Country Intelligence Pages.

• Evaluate 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 degree 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.

• In-depth knowledge of ICH GCP, EU Clinical Trials Directive, and other relevant guidelines for conducting clinical research.

• Experience with regulatory submissions in Australia.

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

🏝️ Benefits

• Health insurance

• Flexible working hours

• Opportunities for professional development

• Paid time off