Regulatory CMC Lead - Latin America

Procter & Gamble; Ciudad de México; Sur place; MXN 800 000 - 1 200 000; Plein temps

Avantages offerts par ce poste

Ownership from Day 1

Mentorship & training

Dynamic, global environment

Flexible work arrangements

Competitive salary and benefits

Résumé du poste

Procter & Gamble in Mexico City seeks a CMC Expert Scientist to lead the preparation, review, and approval of regulatory documentation supporting product renewals, variations, new registrations, and rollouts across Latin America.

You will collaborate with Regulatory Affairs, Product Development, Analytical, Stability, Quality Assurance, and other teams to ensure high-quality dossiers, regulatory compliance, and continuity of supply within the region.

Qualifications

• University degree in Pharmacy, Pharmaceutical Sciences, Chemistry or Life Sciences.
• Experience in regulatory or technical environments, e.g., Regulatory Affairs or Quality Assurance.
• Experience preparing or supporting regulatory documentation for medicinal products and/or food supplements.
• Working knowledge of CTD guidelines, especially Modules 2.3 and 3.
• Understanding regulatory requirements for medicinal products and/or food supplements.
• Strong project management and organizational skills to manage multiple priorities.

Responsabilités

• Plan, author, coordinate, and review submission-ready CMC documentation for medicinal products and food supplements.
• Ensure documents are scientifically sound, accurate, complete, and compliant with CTD standards.
• Maintain alignment between submission docs and supporting data.
• Upload and manage regulatory documents in Veeva RIM and coordinate stakeholder review.
• Serve as primary contact for questions related to technical documents and formatting.
• Collaborate with regional and global teams to address regulatory requirements and risks.
• Manage multiple deliverables with clear plans and timelines.
• Support dossier quality improvement and regulatory processes.

Connaissances

Regulatory documentation

CTD knowledge (Modules 2.3 & 3)

Veeva RIM experience

Technical writing

Cross-functional collaboration

English communication

Project management

Formation

Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or Life Sciences

Outils

Veeva RIM

Description du poste

Procter & Gamble in Mexico City seeks a CMC Expert Scientist to lead the preparation, review, and approval of regulatory documentation supporting product renewals, variations, new registrations, and rollouts across Latin America.

You will collaborate with Regulatory Affairs, Product Development, Analytical, Stability, Quality Assurance, and other teams to ensure high-quality dossiers, regulatory compliance, and continuity of supply within the region.