Consultant, Regulatory Affairs and Quality – Mexico (FSP)
Position Overview
We are seeking a Consultant, Regulatory Affairs in Mexico, to provide primarily operational regulatory support to the Director, Regulatory Affairs & Quality Assurance in Mexico. The role will support execution of regulatory activities for our client´s products, including preparation and coordination of submissions, lifecycle maintenance, regulatory correspondence, commitment tracking, and cross-functional follow-up.
The Director will remain the primary regulatory interface with COFEPRIS and will lead health authority meetings and strategic engagements; the Consultant will support preparation, documentation, and follow-up for those interactions rather than independently leading them.
This is a Full Service Provider (FSP) role sourced through Parexel and embedded in support of our organization. The position is based in Mexico City and follows a hybrid working model, with approximately 50% of working time expected in the Mexico City office.
Key Responsibilities
- Support the Director,



Regulatory Affairs & Quality Assurance – Mexico in the execution of regulatory strategies and priorities for Mexico across the product lifecycle.
- Coordinate regulatory assessments and execution of CMC and manufacturing related changes affecting Mexico, including manufacturing sites, specifications, processes, analytical methods, packaging, and other post-approval changes, in close collaboration with Integral Regulatory CMC, Quality and Supply Chain.
- Coordinate Mexico-specific labeling and artwork regulatory activities, including review of local prescribing information and packaging components, alignment with approved conditions, implementation of safety-related updates, and cross-functional coordination through approval and implementation.
- Demonstrated hands-on experience supporting regulatory procedures before COFEPRIS, including preparation and follow-up submissions, responses to queries, commitments, and po

📌 Consultant, Regulatory Affairs Regulatory Affairs and Quality (Ciudad de México)
🏢 Parexel International
📍 Ciudad de México