What are we recruiting for?

The role is responsible for overseeing global regulatory affairs, quality systems, and compliance across all
manufacturing sites, ensuring alignment with international standards including FDA, EMA, PMDA, and
Health Canada. This includes managing a portfolio of over 50 active regulatory dossiers (DMFs, CEPs, J-
DMFs, etc.), leading end-to-end dossier lifecycle activities from development through post-approval
change management, and acting as the primary interface with regulatory agencies and customers. The
position ensures consistent implementation of GMPs, drives harmonization of quality systems, and
supports both product release and audit readiness globally. With strong integration across development,
manufacturing, and regulatory functions, the role guarantees technical excellence in validation, control
strategy, and analytical integrity while promoting operational excellence and continuous improvement
across sites.

What will you be doing?

• Approve and follow up on activities related to GMPs across all sites
• Act as the primary contact for regulatory agencies and customers
• Maintain, implement, improve, and harmonize the Quality System across all sites
• Analyze, review, and release manufactured products
• Manage external and internal audits, including preparation of audit responses
• Design validation protocols and reports for process manufacturing, cleaning, and analytical procedures
• Assess new projects from a Quality Management perspective
• Detect new trends in Quality to drive continuous review of ESTEVE Global Policies
• Promote operational excellence programs and quality synergies between sites