Regulatory Affairs Specialist – Mexico and Central America

About the role

Pierre Fabre Laboratories, a global leader combining pharmaceutical expertise with dermo-cosmetics, is looking for a Regulatory Affairs Specialist to cover Mexico and Central America (Dominican Republic, Honduras and Guatemala). The role covers regulatory compliance, product registrations, variations and launches.

Key responsibilities

• Prepare regulatory dossiers for new registrations, variations and renewals of medicinal products.
• Manage advertising and promotional materials for pharmaceutical and dermo-cosmetic products.
• Follow up and implement packaging changes for medicines and cosmetics.
• Interact with regulatory authorities (COFEPRIS and Central American agencies).
• Work cross-functionally with Marketing, Supply Chain, Quality and Medical teams.

Required profile

• QFB (Pharmaceutical Chemist Biologist) or related degree.
• At least 3 years of experience in Regulatory Affairs.
• Mandatory experience in the pharmaceutical and dermo-cosmetic industry.
• Knowledge of Central American and Mexican regulatory frameworks.
• Autonomous professional with solid decision-making skills.

Required skills

• COFEPRIS regulations
• Maquila notifications
• Internal corrections management
• Advertising regulatory compliance

What we offer

• Base salary and an annual bonus equivalent to one month of salary.
• A superior benefits package.
• A hybrid work model.