Regulatory Affairs Manager

hace 2 semanas

Guadalajara, México Bebeecompliance A tiempo completo

Regulatory Compliance SpecialistJob Description:We are seeking an experienced Regulatory Compliance Specialist to lead the development and execution of regulatory strategies ensuring full compliance of our product portfolio, nationally and internationally.This includes bioequivalent and bioavailability drugs, medical devices, controlled substances, and imported products.The ideal candidate will act as the key liaison with health authorities such as COFEPRIS, FDA, EMA, as well as international customs and regulatory entities, facilitating agile, safe, and legally sound access of products to the market.:- Design and implement regulatory strategies for the registration, importation, and lifecycle management of pharmaceutical products and medical devices.- Coordinate the preparation and submission of dossiers 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 Mexican Official Standards (NOMs), ICH guidelines, 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.- Lead regulatory audits, manage responses, and ensure timely implementation of corrective actions.- Develop and maintain the Quality Management System Manual, ensuring compliance with Good Manufacturing, Documentation, Storage, and Distribution 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.Required Skills and Qualifications:- Bachelor's degree in Pharmaceutical Chemistry, Biotechnology, Pharmacy, or related fields.- Preferred: Master's or specialization in Regulatory Affairs, Foreign Trade, or Health Legislation.Benefits:Competitive compensation package and industry-leading benefits in the pharmaceutical sector.Join a mission-driven team shaping regulatory excellence on a global scale.Additional Requirements:- Availability to reside in Guadalajara is mandatory for this role.

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