As a Regulatory Systems Leader / Business administrator within our Worldwide Regulatory Affairs (WRA) organization, you will play a role in shaping the future of our Regulatory Information Systems. On a defined perimeter, you will drive the evolution, reliability, and performance of platforms such as RIM (Registration), Promomats, and other regulatory systems supporting business activities.
Your mission: make our regulatory teams more efficient, more connected, and fully empowered through modern, intuitive, and data‑driven systems.

You will join a collaborative, international, and forward‑thinking environment Business Administration team where innovation, and operational excellence are at the heart of everything we do.

Your Key Responsibilities

• Contributes to defining the strategy for regulatory systems.

  • Ensures alignment with regulatory requirements (in compliance with IS validation rules), business needs, and technological evolutions.
  • Conducts active monitoring of regulatory, technological, and methodological developments that may impact the scope.

• Leads and oversees the implementation of the defined strategy and ensures its effective deployment across teams and projects.

  • Translates the strategy into operational actions within the relevant technical scopes, defining priorities, milestones, and roadmaps.
  • Coordinates internal and/or external technical and functional teams involved in execution, promoting communication and the sharing of best practices.

• Provides technical expertise in a complex operational environment to support teams, secure technical decisions, and contribute to the overall performance of the company.

  • Supports teams in analysis, troubleshooting, and technical decision-making; performs complex analyses when required.
  • Contributes to operational risk management related to regulatory systems (obsolescence, end‑of‑life, critical dependencies, etc.).
  • Participates in the onboarding of new team members within the scope of expertise and provides back‑up support on other regulated system areas.

• Ensures user support by strengthening adoption, understanding, and user satisfaction.

  • Works closely with project teams, business functions (e.g., R&D, Pharmacovigilance, Medical Affairs), DAIS, and any other internal or external stakeholders to ensure overall consistency and measure user satisfaction.

As a Business Administrator

• User Support and Operational Management

  • Provides first- and second‑level support to users: incident resolution, user guidance, access management, data relevance and accessibility, compliance with administration processes and regulatory requirements.
  • Analyzes technical issues and their operational impact; provides expertise, recommendations, and solutions.
  • In coordination with DAIS and the wider WRA team, manages functional requests and incidents: requirement collection, impact analysis, solution proposal and implementation.
  • Leads or contributes to user training, ensures communication, and strengthens tool and process adoption.

• Contribution to Releases and System Enhancements

  • Acts as an interface with DAIS and the vendor (e.g., Veeva) on technical topics related to system evolution.
  • Collects business needs, analyzes technical feasibility, and co‑builds solutions aligned with regulatory processes and applicable IS regulations.
  • Drafts technical requirement specifications, integrating business constraints and system capabilities.
  • Manages version upgrades.
  • Performs impact analyses.Defines and executes test plans.
  • Validates production deployment.
  • Ensures regular updates of documentation related to the scope.

Education Level

• Master’s degree (Bac +5). Dual background preferred: Pharmacist, Medical Doctor, or Scientist combined with an IT specialization.

• Or equivalent relevant professional experience.

Experience

• At least 5 years of experience in Regulatory Affairs, and at least 5 years of experience in administering regulatory systems (RIM, Promomats, QMS, eCTD tools or similar).
  OR

• At least 7 years of experience in either Regulatory Affairs or database/system administration, with occasional experience in the other area.

• Experience in direct or indirect management, including project management, is required.