Regulatory & Submissions Lead – Clinical Operations (Hybrid, Paris)

About the role

We are looking for a Regulatory & Submissions Lead to join Parexel’s Clinical Operations team in France. The position works in a hybrid model, requiring at least two days per week on‑site in Paris, and supports a large single sponsor throughout the study lifecycle.

Key responsibilities

• Lead local Ethics Committee and Regulatory Authority submissions, including initial and amendment filings.
• Prepare, submit, and maintain XML documentation required for regulatory dossiers.
• Draft and review informed consent forms using approved templates.
• Manage local investigational medicinal product supply activities and coordinate with vendors.
• Validate translated study documents to meet regulatory requirements.
• Collaborate with cross‑functional study teams to ensure timely approvals and compliance with ICH/GCP, local regulations, and sponsor policies.

Required profile

• Extensive experience preparing independent submissions to Ethics Committees and Regulatory Authorities.
• Strong knowledge of the French regulatory environment, submission pathways, and approval processes.
• Proven ability to work collaboratively across internal and external stakeholders.
• Detail‑oriented mindset with a focus on patient safety and regulatory compliance.

Required skills

• XML documentation preparation for regulatory submissions.
• Validation of translated study documents.