CMC Regulatory Lead - LATAM (Medicinal & Supplements)

2373 P&G Man Mex, S DERLDECV; Ciudad de México; Sur place; MXN 900 000 - 1 300 000; Plein temps

Avantages offerts par ce poste

Competitive salary and benefits

Flexible work schedule

Mentorship and training

Dynamic, supportive environment

Work-life balance

Résumé du poste

Procter & Gamble in Mexico City is seeking an experienced CMC Expert Scientist to lead the preparation, review, and approval of regulatory technical documentation for medicinal products and food supplements across Latin America. You will work with Regulatory Affairs, Product Development, Analytical, Stability, and Quality Assurance teams to ensure compliant, submission-ready dossiers.

The role emphasizes CTD modules 2.3 and 3, collaboration across regions, timely delivery, and continuous

Qualifications

• University degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Life Sciences, or another relevant scientific field.
• Experience in regulatory or technical environment, such as Regulatory Affairs, Quality Assurance, CMC, Product Development, or a related function.
• Experience preparing, reviewing, or supporting technical/regulatory documentation for medicinal products and/or food supplements.
• Working knowledge of CTD guidelines, particularly documentation associated with Modules 2.3 and 3.
• Strong project management and organizational skills, with the ability to manage multiple priorities, timelines, and stakeholders.
• Excellent written and verbal communication skills in English.

Responsabilités

• Plan, author, coordinate, and review submission-ready CMC documentation for medicinal products and food supplements, including CTD Modules 2.3 and 3.
• Maintain alignment between submission documentation, manufacturers' information, and supporting technical data.
• Upload and maintain regulatory documentation in Veeva RIM or applicable document management systems and coordinate stakeholder review and approval.
• Serve as the primary point of contact for questions and feedback related to assigned technical documents, including content and formatting.
• Partner with regional and global multifunctional teams to address regulatory requirements, assess risks and issues, and drive timely resolution.
• Manage multiple deliverables and priorities, developing clear plans and ensuring execution against agreed timelines.
• Support continuous improvement initiatives related to dossier quality, regulatory processes, and complex supply chains.

Connaissances

Pharmacy degree

Regulatory Affairs

CMC documentation

CTD knowledge

Project management

English proficiency

Formation

Pharmacy degree or related field

Outils

Veeva RIM

Description du poste

Procter & Gamble in Mexico City is seeking an experienced CMC Expert Scientist to lead the preparation, review, and approval of regulatory technical documentation for medicinal products and food supplements across Latin America. You will work with Regulatory Affairs, Product Development, Analytical, Stability, and Quality Assurance teams to ensure compliant, submission-ready dossiers.

The role emphasizes CTD modules 2.3 and 3, collaboration across regions, timely delivery, and continuous