Regulatory Affairs Manager - México
Role Summary
We are seeking a dynamic and strategic Regulatory Affairs Manager to lead regulatory compliance and commercial enablement for our Mexico division. This role oversees the full product lifecycle, safety surveillance (Technovigilance/Cosmetovigilance), and external advocacy with health authorities and trade associations.The ideal candidate must have solid experience working with cross-functional teams, in a diverse and multicultural environment and shall be willing to adopt and live the values of the Colgate Palmolive.
Responsibilities:
- Regulatory Strategy: Define and execute regulatory strategies; represent company interests before COFEPRIS and trade associations (e.g., CANIPEC).
- Product Compliance: Manage end-to-end registrations, notifications, and dossier stewardship for Oral, Personal, Home Care, and Medical Device portfolios.
- Safety Surveillance: Serve as the official Technovigilance Unit Responsible Person, managing safety programs (NOM-240-SSA1-2012) and post-market surveillance.
- Operational Leadership: Supervise the local Regulatory Affairs team, manage department budgets, and ensure adherence to local sanitary standards.
Required Qualifications:
- Bachelor’s degree in Pharmacobiological Chemistry, Pharmacy, Chemistry, or Chemical Engineering.
- 7+ years of experience in Regulatory Affairs (Cosmetics/Pharma/Medical Devices)
- 3+ years in a supervisory role
- Proven track record of successful COFEPRIS negotiations supported by a strong history of regulatory compliance and institutional transparency.
- Proficiency in digital regulatory platforms (DIGIPRIS), G-Suite, and AI tools for regulatory workflows.
- Fluent in English (spoken and written).
Preferred Qualifications:
- Master’s/specialization.
- Strong negotiation, analytical decision-making, and leadership capabilities.
- Proven ability to build cross-functional synergies and drive high-performance teams through exceptional communication skills.
- Demonstrated commitment to high ethical standards, corporate governance, and operating in 100% compliance with our Code of Conduct and local anti-corruption frameworks.
Competencies & Core Values:
- Strong negotiation, analytical decision-making, and leadership capabilities.
- Proven ability to build cross-functional synergies and drive high-performance teams through exceptional communication skills.
- Demonstrated commitment to high ethical standards, corporate governance, and operating in 100% compliance with our Code of Conduct and local anti-corruption frameworks.