**Job Objective** Manage, review, and keep updated the documentation of the Quality Management System and Regulatory Affairs, ensuring compliance with current health regulations applicable to the establishment and to the products distributed. **Requirements** **Minimum Education:** Bachelor’s degree in: * Pharmaceutical Chemist-Biologist * Industrial Pharmaceutical Chemist * Pharmacy * Pharmaceutical Engineering * Chemical Engineering * Related field **Professional license and degree certificate are mandatory** **Gender:** Indifferent **Minimum Experience:** 1 year in: * Document control and management * Quality Management Systems * Regulatory Affairs in the pharmaceutical or health supplies sector **Functions and Responsibilities** * Draft, review, control, and update documentation for the **Quality Management System**. * Administer the **Document Control System** (procedures, work instructions, forms, and records). * Support administrative and technical procedures before **COFEPRIS** and other health authorities. * Verify that documentation complies with requirements of applicable **NOMs (NOM\-059, GMP and GDP)**. * Ensure operational procedures are executed in accordance with current health regulations. * Review and prepare documentation for: * Renewal of sanitary registrations * Modifications to registration conditions * Procedures for new products * Track documentation related to COFEPRIS verification visits and internal and external audits. * Keep regulatory documents updated according to regulatory changes and official publications. * Support staff training on documentation and health regulatory matters. * Provide documentary support to the **Pharmacovigilance Unit**, as applicable. **Technical Knowledge** * Quality Management System * Document control * Current health regulations * Administrative procedures before COFEPRIS * Good Distribution and Storage Practices **Competencies** * High sense of responsibility * Organization and adherence to procedures * Attention to detail * Teamwork * Focus on regulatory compliance Employment Type: Full-time Salary: Starting at $12,000.00 per month Work Location: On-site employment