leading cross-functional regulatory projects, ensuring strategic alignment, timeline adherence, risk control, and successful execution across multiple jurisdictions. • Led feasibility assessments, regulatory due diligence, gap analyses, and risk mitigation strategies to reduce compliance exposure and optimize approval timelines. • Led end‐to‐end regulatory dossier management (CTD and regional formats), supervising and executing the preparation, compliance verification, and final consolidation of submissions for small molecules (generics & new molecules), biologics (including biopharmaceuticals), herbal medicines, vitamin medicines, and medical devices (Class I, II, and III), supporting timely submissions and regulatory conformity across diverse portfolios. • Collaborated with global regulatory teams by drafting and preparing clinical and non‐clinical (preclinical) dossier sections aligned with EMA requirements. • Led product classification determinations and technovigilance activities. • Delivered regulatory training programs on medicines and medical devices for pharmaceutical companies, industry chambers, and consulting firms, as well as for internal teams. • Promoted a quality- and compliance-driven culture, ensuring regulatory robustness, consistency across deliverables, and alignment with organizational objectives. ANCE, A.C. – Mexico Head of Medicines Division | Technical Manager | COFEPRIS Authorized Verifier • Directed the Regulatory Afairs function with full accountability for regulatory governance, technical dossier assessment, and high-level decision-making across diversified healthcare portfolios (small molecules — generics and new entities; biologics including biopharmaceuticals; herbal and vitamin medicines), medical devices (Class I–III), dietary supplements, and cosmetics. • Led specialized review teams and defined submission strategies, authorizing the issuance of Favorable Technical Reports as COFEPRIS-Authorized Third-Party Verification Unit • Achieved 360% organizational growth, a 99.7% regulatory approval success rate, and 99.9% client retention, consolidating ANCE’s position as a trusted regulatory partner in third‐party verification services. • Served as principal liaison with COFEPRIS and key stakeholders, atending regulatory inspections and client audits, defining regulatory strategy, conducting high-level technical discussions, and managing complex negotiations and critical compliance maters. • Co‐founded and consolidated the COFEPRIS-Authorized Third-Party Verification Unit for medicines and medical devices, establishing governance, technical procedures, and regulatory credibility, positioning ANCE as a trusted regulatory partner before COFEPRIS. • Strengthened the regulatory assessment function by building and leading a high-performing team, elevating technical rigor, regulatory judgment, and decision-making standards across complex healthcare portfolios. • Drove strategic portfolio expansion through active client acquisition, development, and diversification of the client base, atracting new market segments. • Represented ANCE in national and international regulatory forums, enhancing institutional visibility and forging strategic alliances. • Advanced through progressive roles from Verifier in Training (2014) to Authorized Verifier (2015), Supervisor, Technical Manager before COFEPRIS, and ultimately Head of the Medicines Division (2018), demonstrating sustained performance, technical excellence, and recognized regulatory leadership. KEY ACHIEVEMENTS • Built and scaled two Regulatory Affairs divisions from inception. • Achieved 360% operational growth in regulatory services. • Delivered 99.7% regulatory approval success rate before COFEPRIS. • Sustained >99% client retention through quality and strategic value delivery. • Expanded regulatory service portfolios across Mexico and LATAM. COFEPRIS AUTHORIZATIONS • Authorization No. TA-11-16: Extension for Vitamin and Herbal Medicines. • Authorization No. TA-11-16: Extension for Allopathic Medicines (fractions I–III) and Biotechnological Medicines. • Authorization No. TA-28-13: For Medical Devices, Allopathic Medicines (fractions IV–VI), and Biological Medicines.