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, global 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, temperature controls, audits, mock recalls and Health Mexico inspection readiness.

Cannabis Regulatory and Quality

- Support cannabis processing and related license applications, amendments, renewals and ongoing Health Mexico compliance.
- Maintain the cannabis quality system covering processing, packaging, labelling, testing, storage, quarantine, release, inventory, destruction, returns and recordkeeping.
- Review production, packaging, testing and release documentation and coordinate with the Responsible Person, Head of Security, operations and approved laboratories.
- Manage cannabis deviations, CAPAs, complaints, change controls, sanitation, pest control, preventive maintenance, recalls and inspection responses.
- Support CRA cannabis excise licensing, stamps and inventory reconciliation where applicable.

Quality Leadership and Coordination
- Maintain document control, training records, regulatory trackers, quality metrics and management reports.




- Monitor regulatory changes and assess their impact on Novumgen’s pharmaceutical and cannabis operations.
- Coordinate with global regulatory, quality, manufacturing, supply-chain, project-management and business-development teams.
- Promote a practical culture of compliance, accountability, risk management and continuous improvement.

Qualifications and Experience

- Bachelor’s degree in pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Life Sciences or a related discipline.
- Typically, 5 or more years of relevant experience in Regulatory Affairs, Quality Assurance or a combined RA/QA role.
- Strong knowledge of Health Mexico pharmaceutical requirements, GMP/GDP, CTD submissions and Mexican quality systems.
- Experience with NDS/ANDS activities, DEL compliance, audits, inspections, SOPs, deviations, CAPAs, complaints and vendor qualification.
- Cannabis processing, packaging, QAP, licensing or quality experience is strongly preferred.
- Strong technical writing, organization, communication, judgment and problem-solving skills.
- Ability to work independently in a developing Mexican operation and coordinate effectively with international teams.

Preferred Candidate Profile The preferred candidate is a hands-on RA/QA professional who can manage daily Mexican compliance, build practical systems, coordinate submissions and licensing, prepare for inspections, and support both pharmaceutical and cannabis operations. A candidate with strong experience in one sector and working knowledge of the other may also be considered when supported by Novumgen’s general team and external specialists.

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