Analyst, Regulatory Affairs

Responsibilities

• Support the development of commercial strategies for registration plans and ensure the maintenance of sanitary registrations for local and imported products in Mexico.
• Manage the submission of sanitary registrations, including new registrations, modifications, extensions, and notifications to health ministries.
• Ensure all required technical and legal documentation is obtained and maintained for product approvals in accordance with current Mexican regulations.
• Review promotional materials to ensure regulatory compliance.
• Provide regulatory support for product tender processes and local/corporate change control systems.
• Maintain and update corporate databases for product traceability and tracking of regulatory procedures.
• Prepare pharmacovigilance and technovigilance reports and letters according to current regulations.
• Participate in the review of sanitary legislation and inform relevant departments of changes.

Requirements

• Degree in Pharmaceutical Chemistry, Industrial Chemistry, Pharmaceutical Engineering, or a related field (must be a licensed professional).
• Minimum of 1 year of experience in Regulatory Affairs.
• Professional experience in the pharmaceutical industry, Quality, Manufacturing, or Regulatory Inspections/Audits.
• Strong knowledge of local Mexican sanitary regulations and compliance standards.
• Proficiency in the English language.

Preferred Qualifications

• Post-graduate degree in Administration.

About the Company

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care, and we are now deepening our commitment to elevating the dialysis experience through digital solutions and advanced services while investing in transforming vital organ therapies.