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 post‑appr

📌 Consultant, regulatory affairs and quality (México)
🏢 Parexel
📍 México