Regulatory Submissions Lead — Paris Hybrid

Parexel; Paris; Hybrid; EUR 85,000 - 110,000; Full time

Job summary

Parexel, France (Paris) seeks a Regulatory & Submissions Lead to join our hybrid team, with 2 days per week on site in Paris. You will drive local Ethics Committee and Regulatory Authority submissions, and manage XML documentation for submissions, ensuring compliance with ICH/GCP and country requirements.

You will collaborate with cross-functional teams to support study startup activities and ensure timely regulatory approvals, while maintaining translated documents and informed consent

Qualifications

• Bachelor’s degree or equivalent combination of education and relevant experience.
• Extensive experience in local Ethics Committee and Regulatory Authority submissions.
• Experience independently preparing submissions to Ethics Committees and Regulatory Authorities.
• Experience preparing informed consent forms using approved templates.
• Knowledge of ICH/GCP, regulatory requirements, and clinical trial processes.

Responsibilities

• Lead local Ethics Committee and Regulatory Authority submissions, including initial submissions and protocol amendment submissions.
• Independently prepare and manage submissions to Ethics Committees and Regulatory Authorities.
• Complete and maintain XML documentation as required for submissions.
• Prepare informed consent forms using approved templates.
• Ensure compliance with ICH/GCP, country regulations, sponsor policies and procedures, quality standards, and adverse event reporting requirements.
• Apply in depth knowledge of the local regulatory environment, submission processes, and approval pathways to support study startup activities.
• Manage investigational medicinal product related local supply activities, including coordination with vendors providing background medications and standard of care supplies.
• Review and validate translated study documents to support regulatory and study requirements.
• Support protocol performance and compliance activities across assigned studies within the country.
• Collaborate with study teams and stakeholders to facilitate timely regulatory approvals and study progress.

Skills

Regulatory submissions

Clinical trial startup

Regulatory compliance

Ethics Committee submissions

XML documentation

Informed consent

Communication

Cross-functional collaboration

Attention to detail

Education

Bachelor’s degree or equivalent

Job description

Parexel, France (Paris) seeks a Regulatory & Submissions Lead to join our hybrid team, with 2 days per week on site in Paris. You will drive local Ethics Committee and Regulatory Authority submissions, and manage XML documentation for submissions, ensuring compliance with ICH/GCP and country requirements.

You will collaborate with cross-functional teams to support study startup activities and ensure timely regulatory approvals, while maintaining translated documents and informed consent