Head Of Regulatory Affairs

hace 2 semanas

Guadalajara, México Bebeeregulatory A tiempo completo

Senior Regulatory ExpertAbout the Role:This senior position oversees the regulatory strategies for pharmaceutical products and medical devices in Mexico and internationally.The successful candidate will lead the development and execution of compliance plans to ensure seamless registration, importation, and lifecycle management.Key Responsibilities:Develop and execute regulatory strategies ensuring compliance with international and Mexican regulations.Act as key liaison with health authorities such as COFEPRIS, FDA, EMA, and international customs entities.Design and implement registration, importation, and lifecycle management strategies for pharmaceutical products and medical devices.Coordinate dossier submissions for new registrations, renewals, modifications, and controlled product procedures before COFEPRIS and other agencies.Manage prior import permits including those for controlled substances and regulated raw materials.Ensure compliance with ICH guidelines, NOMs, and other applicable international regulations.Oversee documentation processes including import notices, labeling, certificates of analysis, and free sale certificates.Collaborate closely with quality, logistics, and customs teams to guarantee efficient product flow and regulatory alignment.Develop and maintain the Quality Management System Manual ensuring compliance with Good Manufacturing Practices.Represent the company before regulatory bodies and participate in sectoral forums or working groups.Maintain up-to-date regulatory databases and lead training efforts for the internal regulatory team.About You:We are looking for a highly skilled regulatory expert with strong leadership abilities and extensive experience in regulatory affairs.If you have a passion for staying up-to-date with international and local regulations, we encourage you to apply for this exciting opportunity.

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