1. Martha Alicia García Limón
My pessonal vision, I see myself working in a regulatory department in
a pharmaceutical company o medical device companies and bringing
difference in people life.I’m current working in a pharmaceutical company
commercialization drugs.
I had worked in a development biological application new drug in
stem cells from pulp dental, and therefore I am open for new opportunities
that come along that will position to me to work as senior specialist member
Global regulatory affairs.
Knowledge, Education
Bachelor degree in Pharmacobiological chemist, UNAM, 1993
Proffesional certificate:
Universidad Nacional Autónoma de México 1993
College Degree in Sanitary Risks, conducted by por Camara Nacional de la
industria farmaceútica & Commision Federal for Protection against Sanitary
Risks. (August 2013- March-2014)
Experience
January 2015- Current Regulatory Affairs in Farmmedic SA de CV
Main responsibilities:
Responsible to support General Director in the strategic planning for drugs commercialization for
government, Secretaria de Gobernación (SEGOB), Tribunal Superior de conciliación (TRIFECA), Policia
Federal (PF),conducted by FONDEN (Fondo Nacional de Desastres Naturales).
Responsible to support General Director to work with regulatory policy professionals to keep track in
Mexico Laws and regulatory requirements for procurement of registration documents and provide
Intelligence to head office.
Organizes and maintain reporting schedules for “CUADRO BASICO DE MEDICAMENTOS” of IMSS in
order to provide all requirement drugs to government contracts.
Monitory and follow update health care in web site COFEPRIS, DOF, identifies potential delays or
changes in law, disaster, reject drugs, drugs recall, medical advices.it must be affect our environment
business. Provides operational support in post-registration activities for pesticides, including taxes and
comparison prices of supplier report to General Director.
2011-2015 Regulatory Affairs en Banking Health from Stem Cells, Storeacell & Innovaciones y
Desarrollo en biotecnología sa de cv.
Responsible to regulatory affairs & Administration for Biotechnology laboratory (Stem Cells), Map
different process for protocol of development drugs Stems Cells, phase I. Biotechnology drug dossier for
approval Committee Ethic. Support regulatory for publicity for banking health for COFEPRIS
&CENATRA (Centro Nacional de Transplants de Tejido).
Responsible to Projects established to CONACYT & SECRETARIA DE ECONOMIA for several support of
Government,Support like INNOVAPYME, FINNOVA,Report to General Director of Storeacell (Banking
Health)
Local regulatory dossier for biotechnology drugs for submission regulatory agencies.
2009-2011 Project leader to Cluster North & Packaging Philip Morris International
Provides support and input for submission, timelines during lifecycle (launching for new products,
Renewals for High & Low prices brands, report to Director of Research and Development of PMI.
Responsible to approve labeling Soft &Hard Packs in manufacturing site suppliers in Mexico, Costa
Rica, Dominican & Guatemala for premium Brands.
Responsible to coordinate time & deadlines on stakeholders (Suppliers for cigarette & packs, tobacco,

2. Marketing, production, Logistic) for launching promotions in low and high brands in Mexico,
Guatemala, Costa Rica Dominican in time report to Director of research and development of Mexico.
Policies regulatory from Migration for packs area (Health Warnings) 25 % to 50% from front panel of
High & Low Brands, report to Director of Research and Development of PMI.
Support regulatory regional post-approval commitments and ensure appropriate follow up actions.
1995-2011 Coordinator Quality Assurance & Philip Morris International
Ensure that defined process are developed and implemented within the regional regulatory office to
track and communicate KEY PERFORMANCE INDICATOR (KPI’S) andCentralized periodic Safety update
Report to Quality Assurance.
Responsible to COFEPRIS for lab accredited by ISO 17025 Lab. (Chromatography, oven volatiles,
Sugar, chlorides on tobacco).
Responsible to support with regulatory policies for cigarette given by COFEPRIS in the contain from
Nicotine, CO, Levels of Alquitran .Call Center Cluster North for complains to Clients like disgusting
Flavor, damage packs, incomplete product in convenience store.
LANGUAGES:
Spanish Native
English: Fluently and Writing
SKILL REQUIREMENT:
Advanced Excel
Visual Basic programmer
Project Basic,Statgraphics,Microsoft. Outlook, word, power point
SAP Basico
MAC software
TRAINING:
Administration for goverment projects CONACYT 2013
REYNICYT CONACYT 2013
Project lyfecicle training, methodology Project Management: March 2010, Montreux Switzerland
New software Visual QualityIndex: May 2005 Neuchatel, Switzerland
Training Call center, June 2002 Neuchatel Switzerland
Training Central Quality assurance, 2002 Buenos Aires Argentina
Training Visual Quality Index, 2002 San Josè Costa Rica, Guatemala& Dominicana