Regulatory & Submissions Lead – Clinical Operations Manager

Parexel

. Lead local Ethics Committee and Regulatory Authority submissions, including initial submissions and protocol amendment submissions .

Posted 9/18/2026full-timeParis • FranceSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in managing submissions to Ethics Committees and Regulatory Authorities, ensuring compliance with ICH/GCP and local regulations. Proficient in preparing informed consent forms and managing investigational medicinal product supply activities.

Highest-signal resume keywords

Ethics Committee SubmissionsRegulatory Authority SubmissionsICH/GCP ComplianceInformed Consent Form PreparationInvestigational Medicinal Product Management

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

XML DocumentationSubmission PreparationRegulatory Environment KnowledgeClinical Trial ProcessesDocument Validation

Soft Skills

Strong CommunicationOrganization SkillsProblem Solving Skills

Industry Keywords

Clinical Trial Research AgreementsAdverse Event ReportingStudy Startup ActivitiesBudget DevelopmentPayment Reconciliation

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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
Support protocol performance and compliance activities across assigned studies within France
Collaborate with study teams and stakeholders to facilitate timely regulatory approvals and study progress

Requirements

What you’ll need

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 both Ethics Committees and Regulatory Authorities
Experience preparing informed consent forms using approved templates
Skilled knowledge of the local regulatory environment, submission requirements, and approval processes and their impact on study startup
Experience managing local investigational medicinal product supply activities
Experience validating translated documents
Knowledge of ICH/GCP, regulatory requirements, and clinical trial processes
Strong communication, organization, and problem solving skills
Experience with country and site budget development, negotiation, and completion of Clinical Trial Research Agreements (preferred)
Experience overseeing and tracking clinical research related payments and payment reconciliation activities through study closeout (preferred)

Benefits

Comp & perks

Hybrid work arrangement with at least 2 days per week onsite in Paris
Continuous learning opportunities
Flexibility and growth opportunities