Manager - Regulatory Affairs Quality Mexico
Aviso de fuente externaen NOVUMGEN
NOVUMGEN seeks a Regulatory Affairs and Quality Manager to lead Mexican pharmaceutical and cannabis regulatory activities and quality systems.
Salario
No especificado
Ubicación
Mexico City, México
Tipo de empleo
Tiempo completo
Modalidad
No especificado
Manager - Regulatory Affairs Quality Mexico
Mexico City, México
Descripción del empleo
About the role
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 coordinates Health Mexico submissions and licensing, maintains compliant quality systems, supports DEL and cannabis activities, prepares the organization for inspections, and works with Mexican operations, global teams, manufacturers, laboratories, logistics providers, consultants, and commercial partners.
Responsibilities
- 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.
- 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, and 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, and temperature controls.
Requirements
- The role seeks an experienced Regulatory Affairs and Quality Manager.
Datos clave
- Employment: full-time.
- Department: Regulatory Affairs & Quality.
- The role covers Mexican regulatory and quality activities for pharmaceutical and cannabis operations.
Preguntas frecuentes
What does the role involve?
It leads Mexican regulatory and quality activities for pharmaceutical and cannabis operations, including submissions, licensing, quality systems, and inspection preparation.
What regulatory activities are included?
The role develops Mexican regulatory strategies and coordinates pharmaceutical submissions, regulatory records, licenses, and post-approval changes.
What quality responsibilities are included?
The role maintains the Mexican pharmaceutical quality management system and manages quality issues such as deviations, investigations, CAPAs, complaints, and recalls.