France-Based Regulatory Submissions Lead (Hybrid)

Parexel International; France; Sur place; EUR 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Remote work allowed

Résumé du poste

Parexel is seeking a Regulatory & Submissions Lead to join our France team in a hybrid capacity, with at least 2 days on site in Paris. The role focuses on regulatory submissions, ethics committee interactions, and study startup activities to ensure compliance with ICH/GCP and local regulations.

You will collaborate with cross-functional teams to drive timely approvals and study milestones. This role requires strong attention to detail, excellent communication skills, and a patient-focused

Qualifications

• Bachelor’s degree or equivalent combination of education and relevant experience
• Extensive experience in local Ethics Committee and Regulatory Authority submissions, including initial submissions and protocol amendments
• 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
• Strong communication, organization, and problem solving skills

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

Formation

Bachelor’s degree or equivalent

Description du poste

Parexel is seeking a Regulatory & Submissions Lead to join our France team in a hybrid capacity, with at least 2 days on site in Paris. The role focuses on regulatory submissions, ethics committee interactions, and study startup activities to ensure compliance with ICH/GCP and local regulations.

You will collaborate with cross-functional teams to drive timely approvals and study milestones. This role requires strong attention to detail, excellent communication skills, and a patient-focused