Submission Lead – Structured Data

Sanofi

Submission Lead for Structured Data in Global Submission Management at Sanofi. Leading regulatory data standards implementation for timely, compliant submissions to Health Authorities worldwide.

Posted 7/13/2026full-timeMarcy-l'Etoile • 🇫🇷 FranceSenior💰 €54,400 - €72,533 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in leading structured data operations and managing compliance with global regulatory standards. Proven ability to drive the implementation of IDMP standards and enhance data quality through effective team management and stakeholder collaboration.

Highest-signal resume keywords

Pharmaceutical Regulatory AffairsStructured Data Submission ApplicationsRegulatory Information Management (RIM) SystemsMedicinal Product InformationData Quality Control

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Structured Data OperationsRegulatory Data BackgroundIDMP Standards ImplementationKey Performance Indicators (KPIs)Audit SupportPharmacovigilance RegulationsLife Sciences DegreeInformation Technology Degree

Soft Skills

Team ManagementStakeholder CollaborationCommunication

Industry Keywords

Global Regulatory EnvironmentCompliance RequirementsHealth AuthoritiesRegulatory InnovationService Agreements

About the role

Key responsibilities & impact

Lead structured data operations end-to-end, ensuring timely and compliant submissions to Health Authorities worldwide.
Manage and develop a team of structured data specialists to meet all compliance requirements and quality standards.
Drive the global implementation of IDMP standards and monitor changes to regulatory data requirements.
Represent Sanofi in working groups with Health Authorities and industry partners to shape regulatory innovation.
Oversee data quality control and track Key Performance Indicators (KPIs) to ensure on-time submissions.
Set up and monitor service agreements with vendors and contractors to ensure operational excellence and timely delivery.
Provide expertise during audits and support inspection processes with required documentation and responses.
Work with stakeholders to continuously improve structured data processes and build team expertise.

Requirements

What you’ll need

Extensive pharmaceutical regulatory affairs and/or regulatory data background
Proven hands-on experience in structured data submission applications and RIM systems
Strong knowledge of medicinal product information and global information standards
Understanding of global regulatory environment and Regulatory Information Management (RIM) Systems
Knowledge of pharmacovigilance regulations preferred
Degree in Life Sciences, Information Technology, or related field is preferred
Fluent English (spoken and written) required; Additional language knowledge is a plus

Benefits

Comp & perks

31 days of paid leave + RTT
Remote work up to 2 days/week
Quality health insurance
Public transport coverage up to 80%
Extended maternity/parental leave (18/14 weeks)
Group Savings Plan & PERCOL with employer matching
PERO
Numerous CSE benefits
Internal and international mobility opportunities
Learning & development opportunities