Regulatory Affairs Manager

The Regulatory Affairs Manager is responsible for developing, executing and overseeing the regulatory strategies necessary to ensure compliance of all the 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. It acts as a key liaison with regulatory authorities such as COFEPRIS, FDA, EMA, and international customs or health entities, guaranteeing a legal, agile and safe entry and exit of products to the market. Key Responsibilities: Design regulatory strategies for the registration, importation, and maintenance of pharmaceutical products and medical devices. Coordinate the 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 the 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 the quality management system manual within the organization, ensuring regulatory compliance with good manufacturing, documentation, storage and distribution practices. Represent the 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 the team. Profile Requirements: Education: 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 it is 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 is 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 have superior benefits known in the pharmaceutical industry. Apply now!

Location: México, MX

Posted Date: 6/15/2025