Angel Monroy
Regulatory Affairs Manager in GNC
- Ubicación
- Ciudad de México y alrededores, México
- Sector
- Industria farmacéutica
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Resumen de Angel Monroy
- Actual
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- Regulatory Affairs Manager en GNC
- Regulatory Affairs Project Leader, Mexico and Latin-America en Stendhal Pharma
- Anterior
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- Latin- America Regulatory Affairs Executive en Becton, Dickinson and Company
- Regulatory Affairs Pharma-Biotec Coordinator en GlaxoSmithKline
- Regulatory Affairs en Productos Medix S.A. de C.V.
- Educación
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- Universidad Nacional Autonoma de Mexico
- Universidad Autónoma Metropolitana
- Recomendaciones
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1 persona ha recomendado a Angel
- Contactos
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327 contactos
Extracto de Angel Monroy
5 years in Mexico and Latin-America regulatory affairs as a Project Leader in companies as Stendhal Pharma, Becton Dickinson and Glaxo Smith Kline, for drug products and medical devices. GMP inspection visits experience abroad
Experiencia de Angel Monroy
Regulatory Affairs Project Leader, Mexico and Latin-America
Stendhal Pharma
abril de 2012 – Presente (1 año 3 meses) Av. Camino Santa Teresa No. 1040, Mezanine 1 Col. Jardines en la Montaña Delegac
- Development and implementation of regulatory strategies, health risk evaluator for the best support to the Business units, according to Mexican and Latin-American requirements to ensure the efficacy and safety of medicinal products.
- New Registration (Marketing Authorisation) and Health register variation for high speciality drug products (patented medicinal products and new molecules) for HIV, Hepatitis, Cardiovascular Sickness and Multiple Sclerosis and submissions planner.
- Contact Point with commercial partners and central office for getting an preparing the legal, technical and clinical dossier for submission and health register (marketing authorisation) application.
- Participation in new molecule committee.
- Work in regulatory affairs team for improve local and LATAM regulations (AMIIF, CANIFARMA).
Latin- America Regulatory Affairs Executive
Becton, Dickinson and Company
Empresa pública; Más de 10.001 empleados; BDX; Sector de Servicios médicos
abril de 2011 – marzo de 2012 (1 año)
- Strategy Designer & Health risk valuator, for getting products health registration, renewal & variation.
- Request, review, compile & submission of the product
-Technical, Clinical & Legal Data, according to International (FDA,ISO etc) & National Regulatory.
-Planning, diligence & contribution with the work team common goals.
Regulatory Affairs Pharma-Biotec Coordinator
GlaxoSmithKline
Empresa pública; Más de 10.001 empleados; GSK; Sector de Industria farmacéutica
agosto de 2009 – abril de 2011 (1 año 9 meses)
-Registration of innovate drug products.
-Maintenance of Health Register Products.
-Variation for including or changing new manufacturing sites.
-New molecule commitment
-Development of strategies to reduce approval time & avoid risk that could generate request of additional information from regulatory authorities.
-Search for & implementation of International standars & alternates way, to ensure the complying of local requirements, the quality & safety of products
Cursos de Angel Monroy
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Regulatory Affairs Project Leader, Mexico and Latin-America
Stendhal Pharma
- Risks Minimization
Idiomas de Angel Monroy
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Ingles
Aptitudes y conocimientos de Angel Monroy
Educación de Angel Monroy
Universidad Nacional Autonoma de Mexico
Graduate, Pharmaceutical Administration
2011 – 2011
Universidad Autónoma Metropolitana
BSc Chem, Pharmaceutical, Biology & Health
2005 – 2009
Información adicional de Angel Monroy
- Intereses:
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Investigation, Pharmacovigilance, Workin out of México
- Grupos y asociaciones:
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AMIIF, CANIFARMA
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- Reconocimientos y premios:
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CANACINTRA, Vinculo Universitario-Industria Farmaceutica
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