Hybrid Paris Regulatory Submissions Lead

Parexel; France; Ibrido; EUR 90.000 - 130.000; Tempo pieno

Vantaggi offerti da questo lavoro

Hybrid work model

Descrizione del lavoro

Parexel is seeking a Regulatory & Submissions Lead for France in a hybrid role with two days onsite in Paris. You will drive regulatory submissions, ethics approvals, and study startup activities, ensuring compliance with ICH/GCP and local rules.

You will collaborate with cross-functional teams to support milestones and maintain high standards of quality. You will join a global clinical research partner focused on delivering patient-centric trials and innovative therapies.

Competenze

• Bachelor’s degree or equivalent with relevant clinical/regulatory knowledge.
• Extensive experience in local Ethics Committee and Regulatory Authority submissions.
• Experience preparing informed consent forms and regulatory documents.
• Strong understanding of ICH/GCP and local regulatory requirements.
• Excellent communication, organization, and problem-solving skills.

Mansioni

• Lead local Ethics Committee and Regulatory Authority submissions, including initial and amendments.
• Prepare and manage submissions to Ethics Committees and Regulatory Authorities.
• Maintain XML documentation for submissions.
• Prepare informed consent forms using approved templates.
• Ensure compliance with ICH/GCP, regulations, and sponsor policies.
• Support study startup activities and regulatory approvals timelines.
• Coordinate with vendors for IMP supply and background medications.
• Review translated study documents for regulatory relevance.
• Support protocol performance and compliance across studies.
• Collaborate with study teams to facilitate timely approvals.

Conoscenze

Regulatory submissions

Clinical trial startup

Regulatory compliance

Stakeholder communication

Attention to detail

Cross-functional collaboration

Formazione

Bachelor’s degree or equivalent

Strumenti

XML documentation

Descrizione del lavoro

Parexel is seeking a Regulatory & Submissions Lead for France in a hybrid role with two days onsite in Paris. You will drive regulatory submissions, ethics approvals, and study startup activities, ensuring compliance with ICH/GCP and local rules.

You will collaborate with cross-functional teams to support milestones and maintain high standards of quality. You will join a global clinical research partner focused on delivering patient-centric trials and innovative therapies.