CMC Regulatory Lead: Latin America Submissions

Procter & Gamble; Ciudad de México; Sur place; MXN 600 000 - 900 000; Plein temps

Avantages offerts par ce poste

Day 1 ownership of projects

Mentorship and training

Flexible work schedule

Competitive salary & benefits

Résumé du poste

Procter & Gamble in Mexico City seeks an experienced CMC Expert Scientist to lead regulatory documentation for medicines and food supplements across Latin America. You will coordinate cross-functional teams, ensure CTD-compliant dossiers, and maintain alignment with submission data and external partners.

You will work with Regulatory Affairs, Product Development, Analytical, Stability, and QA to ensure high-quality dossiers, regulatory compliance, and continuity of supply.

Qualifications

• University degree in Pharmacy or related scientific field.
• Experience in regulatory or technical environments (Regulatory Affairs, Quality Assurance, CMC, Product Development).
• Experience preparing or supporting regulatory documentation for medicinal products or food supplements.
• Working knowledge of CTD guidelines (Modules 2.3 and 3).

Responsabilités

• Plan, author, coordinate, and review submission-ready CMC documentation for medicinal products and food supplements.
• Ensure documents are accurate, complete, scientifically sound, and compliant with CTD standards and regulatory requirements.
• Maintain alignment between submission documents, manufacturers' information, and supporting data.
• Upload and maintain regulatory documentation in Veeva RIM or similar systems and coordinate reviews.
• Serve as primary contact for questions related to technical documents, including content and formatting.
• Collaborate with regional/global teams to address regulatory requirements and drive timely resolutions.
• Manage multiple deliverables with clear plans and timelines.
• Support dossier quality and regulatory process improvements across supply chains.

Connaissances

Regulatory Affairs

CMC Documentation

Project Management

English Proficiency

Cross-functional Collaboration

Formation

Bachelor's degree in Pharmacy or related field

Outils

Veeva RIM

Description du poste

Procter & Gamble in Mexico City seeks an experienced CMC Expert Scientist to lead regulatory documentation for medicines and food supplements across Latin America. You will coordinate cross-functional teams, ensure CTD-compliant dossiers, and maintain alignment with submission data and external partners.

You will work with Regulatory Affairs, Product Development, Analytical, Stability, and QA to ensure high-quality dossiers, regulatory compliance, and continuity of supply.