Regulatory Affairs Manager - CMC

Procter & Gamble; Ciudad de México; On-site; MXN 600,000 - 900,000; Full time

Benefits offered by this job

Day 1 ownership of projects

Mentorship and training

Flexible work schedule

Competitive salary & benefits

Job summary

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).

Responsibilities

• 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.

Skills

Regulatory Affairs

CMC Documentation

Project Management

English Proficiency

Cross-functional Collaboration

Education

Bachelor's degree in Pharmacy or related field

Tools

Veeva RIM

Job description

Job Location

MEXICO CITY GENERAL OFFICE

Job Description

Important Note for Candidates: Accommodations: At P&G, we are committed to ensuring an inclusive recruitment, assessment, and selection process. If you have a disability and require any adjustments or accommodations for our assessments or any stage of the process, you will have the opportunity to briefly describe your needs when applying for the vacancy. Please note, it is important that you do not complete any assessments until we have contacted you to assist with any accommodation required.

As a CMC Expert Scientist, you will lead the preparation, review, and approval of technical regulatory documentation supporting product renewals, variations, new registrations, and rollouts across Latin America. You will primarily support the Base Business portfolio, while also having the opportunity to contribute to innovation projects as needed. Working closely with Regulatory Affairs, Product Development, Analytical, Stability, Quality Assurance, and other multifunctional teams, you will help ensure high-quality dossiers, regulatory compliance, and continuity of supply across the region.

Key Responsibilities

• Plan, author, coordinate, and review submission-ready CMC technical documentation for medicinal products and food supplements, including CTD Modules 2.3 and 3 and Food Supplement Master Dossiers.
• Ensure technical documents are accurate, complete, consistent, scientifically sound, and compliant with applicable CTD standards and regulatory requirements.
• Maintain alignment between submission documentation, manufacturers' information, and supporting technical/raw 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.

Job Qualifications

• Top Qualifications
  • University degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Life Sciences , or another relevant scientific field.
  • Experience working in a 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 .
  • Understanding of regulatory requirements and guidelines applicable to medicinal products and/or food supplements .
  • Strong project management and organizational skills, with the ability to manage multiple priorities, timelines, and stakeholders .
  • Strong collaboration and influencing skills, including the ability to work effectively across functions and regions.
  • Ability to clearly and assertively communicate technical risks, issues, and recommended actions .
  • Excellent written and verbal communication skills in English.
• Nice to Have
  • Knowledge of Latin American regulatory requirements for medicinal products and/or food supplements.
  • Previous experience with marketing authorizations, product registrations, renewals, or variations .
  • Experience with Veeva RIM or similar regulatory/document management systems.
  • Experience working with regional or global multifunctional teams .
  • Experience supporting complex supply chains or multiple manufacturing sites .
  • Spanish language proficiency.
  • Experience supporting innovation projects or new product registrations.

What we offer!

• We'll give you responsibilities as of Day 1 - you will feel the ownership of your project from the beginning, and you will be given specific projects and responsibilities
• You’ll have continuous mentorship - you will work with passionate people and receive both formal training as well as day-to-day mentoring from your manager
• We offer you to work and be part of a dynamic and supportive environment
• We promote agility and work/life balance for employees, we value every individual and support initiatives, promoting.
• We love flexibility. You can arrange your work schedule based on your personal needs
• We will let you experience true support for work/life effectiveness and your long-term well being
• We will give you a competitive salary and benefits' package.

About us!