Submission Lead

Job Title

Submission Lead

Location

Marcy l’ Étoile or Gentilly

About the job

As Submission Lead within our Global Submission Management (GSM) team, you will lead the implementation of cutting‑edge regulatory data standards and ensure timely, compliant submissions to Health Authorities worldwide. You will play a key role in ensuring that medicinal product information is submitted in standardized, structured formats, directly contributing to patient safety and regulatory efficiency at a global scale.

Main responsibilities

• 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.

What we offer you

We provide a fixed salary over 12 months, supplemented by a short‑term incentive and a collective variable compensation based on Sanofi Group results.

• 31 days of paid leave + RTT depending on your status.
• Remote work up to 2 days per 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 and numerous CSE benefits.
• Internal and international mobility opportunities.
• Learning & development opportunities.

Salary and Compensation

The salary range for this position is €54 400,00 – €72 533, with final compensation determined by demonstrated experience, skills, location, and other relevant factors.

Experience

• Extensive pharmaceutical regulatory affairs and/or regulatory data background, with 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.

Soft & Technical Skills

• Strong influencing abilities to drive compliance across affiliate organizations and educate teams on structured data submission subjects.
• Excellent organizational and project management skills to handle complex, multi‑stakeholder initiatives.
• Continuous improvement mindset with focus on process optimization and subject‑matter expertise development.

Education

Degree in Life Sciences, Information Technology, or related field is preferred.

Languages

• Fluent English (spoken and written) required.
• Additional language knowledge is a plus.

Why choose us?

• Lead and be the Subject Matter Expert for the global transition to IDMP standards, a transformative regulatory initiative that modernizes data exchange with Health Authorities worldwide.
• Drive meaningful impact on priority portfolio regulatory submissions with visibility into a strategically important business area.
• Develop your career with access to cross‑functional moves and opportunities to grow across a global regulatory network.
• Collaborate with leading regulatory experts, data specialists, and Health Authorities in a purpose‑driven community dedicated to patient safety.

EEO Statement

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.