Álvaro Obregón, Mexico City, Mexico
Motivated to contribute to the regulatory field by managing submissions, validating documentation, and supporting regulatory processes in the pharmaceutical industry. Experienced in regulations like RTCA and the CTD format, with skills in using platforms such as Veeva Vault RIM and PromoMats for efficient documentation management. Organized, results-driven, and committed to ensuring regulatory excellence to deliver healthcare solutions to those who need them most. Always eager to grow and contribute value in a dynamic, collaborative environment.
As a Regulatory Affairs Sr. Analyst, I manage the pain medication and part of controlled substances portfolio, ensuring strict compliance with COFEPRIS and ICH guidelines. My focus is on securing timely approvals through rigorous dossier preparation and strategic product lifecycle management for the Mexican market. Key responsibilities: Product Lifecycle Management: Executing post-authorization changes (major, moderate, and minor changes), renewals, responses to health authority queries, and the inclusion of new therapeutic indications to maintain marketing authorizations. New Registrations & Regulatory Strategy: Compiling comprehensive technical dossiers for new generic drugs. Additionally, I possess a strong understanding of abbreviated regulatory pathways (Reliance) for the submission of New Molecular Entities in Mexico. Artwork & Labeling: Coordinating with design and cross-functional teams to oversee the creation, review, and implementation of packaging materials (artwork), Prescribing Information (PI), and patient information leaflets (PIL) Cross-functional Collaboration: Partnering with Supply Chain and Quality departments to design regulatory strategies for product importation, annual reporting, and storage compliance. Regulatory Systems: Utilizing and maintaining internal corporate systems, including Veeva Vault, Trackwise, and D2, to ensure tracking and traceability of all submissions and organizational processes.
Provided support for the preparation and submission of dossiers for Marketing Authorizations, Renewals, and Modifications for high-specialty medicines (synthetic, biotechnological, and orphan drugs) in Central American countries (RTCA), Dominican Republic, and Andean countries (Peru, Ecuador, and Colombia). Responded to inquiries from regulatory authorities in Central America and Colombia for synthetic and orphan drugs, achieving the renewal of a marketing authorization for a synthetic medicine in Panama. Coordinated requests and dispatches of administrative and legal documents to comply with specific country requirements. Reviewed and validated regulatory materials (Artwork, Prescribing Information and Patient Information Leaflet) to ensure compliance with applicable regulations, such as RTCA and Colombian standards. Implemented a Quality Management System (QMS) under ISO 9001:2015 standards to improve regulatory process control. Effectively applied the CTD format for the preparation and submission of regulatory dossiers in Latin America. Managed regulatory processes and legal documents using Veeva Vault RIM, as well as controlled and maintained artworks (labels, monographs, and inserts) using Veeva Vault PromoMats.