Regulatory Compliance Specialist

Regulatory Affairs Professional The Regulatory Affairs Manager is responsible for developing, executing and overseeing the regulatory strategies necessary to ensure compliance of all products handled by the organization both nationally and internationally. Its focus includes bioequivalent and bioavailability drugs, medical devices, controlled drugs as well as imported products. Key Responsibilities: Design regulatory strategies for registration, importation and maintenance of pharmaceutical products and medical devices. Coordinate preparation and submission of dossiers for new registrations renewals modifications and procedures for controlled products before COFEPRIS and other regulatory agencies. Manage prior import permits including controlled products and substances subject to special regulation. Ensure compliance with official Mexican standards NOMs ICH guidelines and applicable international regulations. Supervise correct documentation and processing of import notices labeling certificates of analysis and certificates of free sale. Coordinate with areas such as quality logistics and customs to ensure efficient processes of entry and exit of products. Lead regulatory audits and follow up on corrective actions. Responsible for carrying out quality management system manual within the organization ensuring regulatory compliance with good manufacturing documentation storage and distribution practices. Represent company before regulatory authorities and actively collaborate in forums or working groups in the sector. Keep regulatory databases up to date and ensure continuous training of team. Profile Requirements: Bachelor's degree in Chemistry Pharmacy Biotechnology or related career. Desirable: Specialty or master's degree in Regulatory Affairs Foreign Trade or Health Legislation. Quality Management Systems a plus. Experience: Minimum 5–7 years in regulatory affairs in pharmaceutical industry in medicines controlled and medical devices. Direct experience with sanitary import procedures prior permits and customs processes. Solid knowledge in bioequivalent products medical devices and controlled drugs. Management of regulatory platforms Digipris VUCEM CECI among others. Proven relationship with COFEPRIS SSA Customs and international authorities. Know-how: National and international health legislation NOMs ICH FDA EMA WHO. Foreign trade regulations Customs Law international treaties COFEPRIS rules and criteria. Health control of controlled substances psychotropic drugs and narcotics. Management of clinical studies and documentation of bioavailability/bioequivalence. Advanced English essential desirable second language. Key Competencies: High regulatory and technical mastery. Leadership and decision-making. Strategic planning and tactical execution. Effective communication with authorities and internal teams. Risk Management and Regulatory Troubleshooting. Organization attention to detail and precise follow-up. Professional ethics and legal responsibility. We offer superior benefits known in pharmaceutical industry Apply now

Creado: Jue, 01 de Ene de 1970