MONICA MONTES DE OCA JIMENEZ
Summary
Professional with more than con 9 years of experience in the area of regulatory affairs, providing my experience and carrying out regulatory affairs processes for a wide portfolio of products for human use. 1 year of experience as sanitary responsible of my own pharmacy.
Problem-solving, attention to detail, decision-making, multitasking, teamwork, and effective communication.
Overview
10
10
years of professional experience
4
4
years of post-secondary education
1
1
Language
Work History
Sanitary responsible
Pharmacy
06.2023 - Current
- Carry out the registration process and necessary variations in the operating permit
- Ensure regulatory compliance of the establishment
- Ensure the compliance of first-expired first-out (FEFO) system for all the products
- Review and sign the temperature and relative humidity records
- Creation and update of the Standard Operating Procedures (SOP)
Regional chief of regulatory affairs LATAM
Laboratorios Sanfer S.A. de C.V.
01.2021 - 06.2023
- Team leadership
- Planning and control of the team activities
- Determining effective regulatory strategies
- Dossier review
- Monitoring of applications for new registration, variations and renewals of marketing authorizations, until approval.
- Review of advertising materials
- Effective communication with internal and external people
Regional coordinator of regulatory affairs LATAM
Laboratorios Sanfer S.A. de C.V.
07.2018 - 12.2020
- Planning the submissions for the Central America region
- Integration and review of dossiers
- Budget control
- Review and harmonization of labeling in LATAM
Regulatory affairs analyst LATAM
Laboratorios Sanfer S.A. de C.V.
06.2015 - 06.2018
- Integration of dossier for diverse kind of products, such as medicines, medical devices and cosmetics for submission before the ministries of health in Central America, the Caribbean, and South America
- Control of legal documents
- Carry out legalization and apostille process for legal documents
- Review of product labeling to ensure compliance
Regulatory affairs intern
Laboratorios Columbia S.A. de C.V.
06.2014 - 06.2015
- Integration of dossier for diverse kind of products, mainly medicines, medical devices and herbal medicine
- Support in the import of Controlled Active Pharmaceutical Ingredients
- Generation of periodical safety reports
- Support in the implementation of ISO 9001 system
- Internal audits
Education
Industrial Pharmaceutical Chemist - undefined
Instituto Politecnico Nacional
01.2010 - 05.2014
Skills
Microsoft Office
Timeline
Sanitary responsible
Pharmacy
06.2023 - Current
Regional chief of regulatory affairs LATAM
Laboratorios Sanfer S.A. de C.V.
01.2021 - 06.2023
Regional coordinator of regulatory affairs LATAM
Laboratorios Sanfer S.A. de C.V.
07.2018 - 12.2020
Regulatory affairs analyst LATAM
Laboratorios Sanfer S.A. de C.V.
06.2015 - 06.2018
Regulatory affairs intern
Laboratorios Columbia S.A. de C.V.
06.2014 - 06.2015
Industrial Pharmaceutical Chemist - undefined
Instituto Politecnico Nacional
01.2010 - 05.2014
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<ul><li>Vacuumed rugs and carpeted areas in offices, lobbies and corridors.</li><li>Polished glass surfaces and windows.</li><li>Washed, cleaned and disinfected water coolers.</li><li>Dusted picture frames and wall hangings with a cloth.</li><li>Removed waste paper and other trash from the premises to designated area.</li><li>Operated power equipment tools such as backpack vacuums for up to 2 hours per shift.</li><li>Changed bed linens and collected soiled linens for cleaning.</li><li>Disinfected and mopped bathrooms to keep them sanitary and clean.</li><li>Collected trash and moved garbage cans from kitchen areas to pick-up stations.</li><li>Cleaned walls, windows, shades and curtains.</li><li>Used chemicals and other cleaning equipment in a proper, safe and responsible manner.</li><li>Cleaned and changed bedspreads, blankets and mattresses.</li></ul> at Kaimanawa Timeshares<ul><li>Vacuumed rugs and carpeted areas in offices, lobbies and corridors.</li><li>Polished glass surfaces and windows.</li><li>Washed, cleaned and disinfected water coolers.</li><li>Dusted picture frames and wall hangings with a cloth.</li><li>Removed waste paper and other trash from the premises to designated area.</li><li>Operated power equipment tools such as backpack vacuums for up to 2 hours per shift.</li><li>Changed bed linens and collected soiled linens for cleaning.</li><li>Disinfected and mopped bathrooms to keep them sanitary and clean.</li><li>Collected trash and moved garbage cans from kitchen areas to pick-up stations.</li><li>Cleaned walls, windows, shades and curtains.</li><li>Used chemicals and other cleaning equipment in a proper, safe and responsible manner.</li><li>Cleaned and changed bedspreads, blankets and mattresses.</li></ul> at Kaimanawa Timeshares