Regulatory Affairs & Quality Coordinator

We are Theramex, a global specialty pharmaceutical company solely committed to supporting the health needs of women through every stage of life.

We work closely with our partners, healthcare professionals, and patients to help women find the solution that may be right for them at the time they most need it .

Job Purpose

Act as responsible for obtaining and maintaining Theramex product registrations and licenses in compliance with COFEPRIS regulations, while collaborating closely with global and regional teams to ensure the integration of local needs into broader strategies and maintain the highest standards of quality and regulatory practice.

Key Duties and Responsibilities

The following key activities from a regulatory perspective :

• Proactively seek information and opportunities that can accelerate review and approval timelines
• Map and influence key internal and external stakeholders to streamline regulatory pathways
• Build and maintain strong relationships with external regulatory bodies such as COFEPRIS, industry associations, and other relevant authorities
• Dossier management and post-approval maintenance
• Submission of applications, response to technical requirements, and scheduling meetings with authorities
• Maintenance of applicable operational licenses
• Provide expert regulatory advice and ensure strategic alignment with global and local business goals
• Interpret and enforce relevant standards and operating procedures, addressing complex technical regulatory issues
• Oversee project management and execution of all phases of the regulatory lifecycle
• Coordinate the distribution and tracking of documentation related to product registration and commercialization in Mexico
• Lead regulatory evaluations to determine product classification and licensing requirements
• Drive new regulatory projects to expand the product portfolio
• Support the oversight of the local Marketing Authorization Holder
• Oversee the preparation of regulatory policy reports
• Review marketing materials to ensure compliance with regulatory requirements
• Provide training on regulatory aspects, including product information, procedures, and best practices for storage and distribution

The following key activities from a quality perspective :

Minimum Requirements (experience & education)