Description

Senior Regulatory Affairs Expert with over 10 years of experience in the pharmaceutical, food supplement, cosmetic, and medical device industries. I have led and executed regulatory registration projects for medicines (Rx and OTC), food supplements, and cosmetics across Europe and Latin America. Specialized in regulatory due diligence, market entry strategies, labeling review, and compliance with EMA, EFSA, ANMAT, COFEPRIS, DIGEMID, and other authorities. I support companies from regulatory planning to post-approval maintenance, ensuring both efficiency and compliance.

Industry field of expertise

Languages

Spanish
Native or bilingual
English
Fluent

Workplace preferences

Can work on-site

Barcelona (up to 20km)

Eprofar
Regulatory Advisor Independed (Regulatory)
PHARMACEUTICALS INDUSTRY
May 2020 - Today (6 years and 1 month)
Barcelona, Spain
Independent advisor of the regulatory area for the national and multinational industry and professionals of health.
• Coordinate Regulatory Submission plans of pharmaceutical, biological product, Cosmetics, Medical Device, Orphan drugs in the region: México, Colombia, Argentina, Chile, Perú, Ecuador, El salvador, Guatemala, Panamá, Rep. Dominicana, Hondura, Nicaragua and Venezuela.
• Activities related life cycle of pharmaceutical and biological product, cosmetics, medical devices.
• Review of CTD (Commun Technical document).
• Advise in the identification and diagnosis of problems, faults or deficits in an integral way related with the regulatory strategic.
• Implement improvement tools to raise efficiency, productivity and competitiveness indicators.
• Training of personnel in regulatory affairs, quality assurance, pharmacovigilance, GMP, GDP.
• Management of the sanitary regulation (Argentina/ANMAT, Chile/ISP, Colombia/INVIMA, Ecuador/ARCSA, CENAM, Perú/DIGEMID, México/ COFEPRIS, Venezuela/INHRR) and updated of regulations in force in Latin American and international countries (EMA, FDA and guidelines).
• Customer service and advise on new legislation and regulatory guidelines.
Galenicum Health
Senior Regulatory Affairs Expert
April 2019 - May 2020 (1 year and 1 month)
Barcelona, Spain
• Responsible of the company to get approval of Sanitary Registration/ Variations and Renewals of Pharmaceuticals Products with the Health Authority of Latin American countries (Chile/ISP, Colombia/INVIMA, Ecuador/ ARCSA, México/COFEPRIS and CENAM). Tracking of the product status and liaising and negotiating with health authorities for registration approvals.
• Create and design regulatory strategy for the compliance the aims of the company with team management (grouping and worksharing) and work active with the team of managers of the company.
• Training of personnel for audits of dossier and regulations in Latam.
• Responsible of audits and reports of dossier of oncological drugs and nervous system central.
• Management of the sanitary regulation (Chile, Colombia, Ecuador, CENAM & México) and updated of regulations in force in Latin American and international countries (EMA, FDA and guidelines ICH).
• Responsible for check and approval of marketing materials for Latin American Countries.
Laboratories Vargas, S.A.
Manager Regulatory Affairs - Sponsor/Gerente de Asuntos Regulatorios
May 2013 - April 2016 (2 years and 11 months)
Grupo Vargas, La Zubia, AN, Spain
• Active participation and multidisciplinary with the team of manager´s for design and establish strategic guidelines based on corporate objectives with the committees: Committees of New Products, National and International Registries, Attracting third parties for manufacturing of products System Quality Management Plant.