Regulatory & Submissions Lead — Paris (Hybrid)

Parexel; France; Hybride; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Parexel in France is seeking a Regulatory & Submissions Lead to join our team in a hybrid capacity, with at least two days per week onsite in Paris. The role is accountable for performance and compliance across assigned clinical trial protocols, ensuring adherence to ICH/GCP guidelines and local regulations.

As a key contributor to study startup and execution, you will drive regulatory and ethics submissions, maintain compliance, and support critical milestones through collaboration with cross

Qualifications

• Bachelor's degree or equivalent with relevant experience.
• Extensive experience in Ethics Committee and Regulatory Authority submissions.
• Experience preparing informed consent forms and translation review.

Responsabilités

• 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

Connaissances

Regulatory submissions

Clinical trial startup

Ethics Committee submissions

Regulatory Authority submissions

Formation

Bachelor's degree or equivalent

Description du poste

Parexel in France is seeking a Regulatory & Submissions Lead to join our team in a hybrid capacity, with at least two days per week onsite in Paris. The role is accountable for performance and compliance across assigned clinical trial protocols, ensuring adherence to ICH/GCP guidelines and local regulations.

As a key contributor to study startup and execution, you will drive regulatory and ethics submissions, maintain compliance, and support critical milestones through collaboration with cross