Specialist, Regulatory & Site Activation

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

📋 Description

• Collaborate with SAR colleagues to effectively plan, organize, compile, progress, track, and submit regulatory submissions promptly and with a consistently high standard of quality.

• May serve as a point of contact for the review of translation for submission documents, including applications, synopses, informed consent forms (ICFs), labels, and more.

• Update and maintain country-specific patient information sheets and customize consent form texts.

• Ensure the upkeep of country-specific drug labeling information and Country Intelligence Pages.

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

⛳️ Requirements

• A bachelor's degree with a major focus in medical, biological, physical, health, pharmacy, or other related sciences.

• At least two years of experience in clinical research, ideally with a focus on site activation and/or regulatory functions.

• Previous experience in the pharmaceutical or CRO industry is preferred.

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

• Multilingual candidates are preferred; fluency in the local language and a working knowledge of English is required.

• Candidates must possess substantial experience in the regulatory process specific to Brazil to qualify for this position.

🏝️ Benefits

• Diverse and inclusive work environment.

• Accessible leadership.

• Supportive teams.