International Regulatory Affairs

Description

Position Summary: We are seeking an International Regulatory Affairs Specialist to manage registration dossiers, variations, and renewals of pharmaceuticals and medical devices in global markets. Key Highlights: 1. Manages technical and legal information for international registrations. 2. Prepares and maintains dossiers in CTD and ACTD formats. 3. Monitors national and international regulatory updates. A Mexican pharmaceutical company specializing in pharmaceuticals (injectable solutions, anesthetics) for the dental sector and medical devices is hiring: **International Regulatory Affairs Specialist.** **Position Objective** To manage technical and legal information for registration dossiers, variations, preventive actions, and renewals of pharmaceuticals, medical devices, and cosmetics in international markets (Central and South America, the Caribbean, Europe, Asia, and Africa). To process certificates of free sale, certificates of good manufacturing practice, and sanitary verification visits. **Responsibilities** * Prepare and maintain dossiers in CTD (M1–M3\) and ACTD formats. * Track regulatory submissions and respond to regulatory observations. * Review approval letters and annexes (labels, instructions for use, prescribing information). * Comply with documentation and change control requirements per the quality management system. * Manage legal/technical information and samples for registrations, variations, and renewals of pharmaceuticals, medical devices, and cosmetics. * Assess national changes and their impact on international registrations. * Renew legal documents and manage translations/certifications. * Participate in foreign sanitary verification visits. * Monitor national and international regulatory updates. **Requirements** * Education: Bachelor’s degree in Pharmaceutical Chemistry and Biology or related field; professional license preferred. * Experience: Minimum 2 years in international regulatory affairs and dossier preparation. * Knowledge: ICH guidelines (CTD), USP, FEUM, General Health Law, Regulations for Health Inputs, NOM\-059, NOM\-072, NOM\-220, RCTA. * English: B2 level\. **Working Hours:** * Monday to Friday, 8:00 AM to 6:00 PM (1-hour lunch break). * 3 days onsite and 2 days remote work. Compensation * Daily salary: $751\.62 * Monthly salary: $22,861\.78 * Attendance bonus: $1,503\.24 * Punctuality bonus: $1,503\.24 * Grocery vouchers: $2,286\.18 * Savings fund: $939\.52 * **Total monthly salary: $29,093\.96** (pre-tax) **Benefits** * Subsidized cafeteria * Grocery vouchers (10%) * Savings fund (4%) * Vacation days as per Federal Labor Law (LFT) plus proportional accrual starting at 6 months * 5 additional paid leave days * Seniority, retirement, and academic achievement bonuses * Half-day off on your birthday * Marriage support (3 additional days) * Savings box and employee referral program * Support for studies and internal English classes * Discounts on Zeyco products and partnerships with gyms, spas, and swimming pools. In-house English classes funded by the company. Salary: $29,093\.96 per month Benefits: * Study support * Free beverages * Employee discount * Gym discount * Company parking * Free parking * Option for indefinite-term contract * Discounted cafeteria service * Remote work * Grocery vouchers Experience: * Similar position: 2 years (Mandatory) Language: * English (Mandatory) Work Location: On-site employment