Regulatory Affairs & Quality Manager - Mexico

Employment
Full-time

Department
Regulatory Affairs & Quality

Reports to
Senior Management

Position Summary:

Novumgen is seeking an experienced Regulatory Affairs and Quality Manager to lead Mexican regulatory and quality activities for its pharmaceutical and cannabis operations. The role will coordinate Health Mexico submissions and licensing, maintain compliant quality systems, support DEL and cannabis activities, prepare the organization for inspections, and work closely with Mexican operations, integral teams, manufacturers, laboratories, logistics providers, consultants and commercial partners.

Key Responsibilities:

Pharmaceutical Regulatory Affairs
Develop and manage Mexican regulatory strategies and submission plans for pharmaceutical products.
Prepare, review and coordinate NDS, ANDS, supplements, amendments, notifications, deficiency responses, DIN-related activities and post-approval changes.
Coordinate CTD Modules 1 and 2 and review consistency with technical Modules 3, 4 and 5.
Manage product monographs,



bilingual labels, package components, product names and regulatory correspondence with Health Mexico.
Maintain submission trackers, approvals, licenses, commitments, product timelines and regulatory records.

Pharmaceutical Quality and DEL Compliance
Establish and maintain the Mexican pharmaceutical quality management system, including SOPs, forms, specifications, protocols, reports and quality agreements.
Support Drug Establishment License applications, amendments, renewals, foreign building evidence, importation, packaging, labelling, testing, storage and distribution activities.
Manage deviations, investigations, CAPAs, change controls, complaints, recalls, returns, risk assessments and product quality issues.
Qualify and monitor manufacturers, API suppliers, laboratories, warehouses, distributors, third-party logistics providers and other vendors.
Support batch-document review, release requirements, t

📌 Manager - Regulatory Affairs & Quality (Mexico) (Ciudad de México)
🏢 NOVUMGEN
📍 Ciudad de México