Regulatory and Start Up Specialist

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

📋 Description

• Execute tasks related to Site Activation (SA) activities in compliance with regulatory standards.

• Act as the Single Point of Contact (SPOC) for investigative sites and project teams.

• Ensure compliance with standard operating procedures (SOPs) and project timelines.

• Prepare and disseminate site regulatory documents.

• Conduct quality control on documents submitted by sites.

⛳️ Requirements

• Bachelor’s Degree in life sciences or a relevant field.

• 3 years of clinical research experience, with at least 1 year in a leadership role.

• An equivalent combination of education, training, and experience will be considered.

• Comprehensive understanding of clinical systems, procedures, and corporate standards.

• Familiarity with GCP/ICH and applicable regulatory guidelines, along with the ability to apply them.

• Awareness of relevant regulatory requirements, including local regulations, SOPs, and the company’s Corporate Standards.

• Knowledge of the regulated clinical trial environment and the drug development process.

🏝️ Benefits

• French fluency is a requirement.

• This position is Home Based.