Alfonso Lomas
International Regulatory Affairs Manager, PV Coordinator & Materiovigilance Responsible at MANA PHARMA, S.L.- Claim this Profile
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English Full professional proficiency
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Italian Professional working proficiency
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Spanish Native or bilingual proficiency
Topline Score
Bio
Credentials
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Actualización en Buenas Prácticas de Distribución Farmacéutica
Consejo General de Colegios FarmacéuticosOct, 2022- Oct, 2024 -
Certificate in Advanced English (C1)
University of Cambridge -
First English Certificate (B2)
University of Cambridge -
Italiano Livello B2
Università degli Studi di Firenze -
Preliminary English Test (B1)
University of Cambridge
Experience
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MANA PHARMA, S.L.
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Spain
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Pharmaceutical Manufacturing
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1 - 100 Employee
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International Regulatory Affairs Manager, PV Coordinator & Materiovigilance Responsible
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Jan 2023 - Present
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International Regulatory Affairs Technician, PV Coordinator & Materiovigilance Responsible
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Jul 2022 - Jan 2023
• Management of the registration procedure for medicines in LATAM and MEA.• Preparation, management and presentation of variations, renewals and other procedures to ensure the maintenance of registrations.• Support in external audits.• Coordination and direct contact with clients, suppliers and corresponding authorities.• Revision and translation of registration materials.• Participation in projects development, ensuring compliance with regulatory requirements applicable in each territory.• Revision and filing of pharmacovigilance documentation.• Coordination of pharmacovigilance activities.• Revision and translation of web and advertising materials. Show less
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Farma Leaders Talento
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Spain
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Member
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2022 - Present
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Pharmex Advanced Laboratories
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Spain
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Regulatory Affairs, Quality Assurance & Pharmacovigilance Technician
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Jul 2021 - Jul 2022
• Support in the creation of a new QA system from scratch. • Revision and creation of new SOPs. • Registration in the different product categories in the CAM. • Adaptation and revision of AWs for all products. • Support in the creation of a new QA system from scratch. • Revision and creation of new SOPs. • Registration in the different product categories in the CAM. • Adaptation and revision of AWs for all products.
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Pharmacist
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Apr 2020 - Aug 2021
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Pharmacist
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May 2019 - Jul 2019
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Hospital Universitario Virgen de las Nieves
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Spain
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Medical Practices
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1 - 100 Employee
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Pharmacist
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Feb 2019 - Apr 2019
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Education
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CESIF
Master's degree, Industria Farmacéutica y Parafarmacéutica -
Università degli Studi di Firenze
Grado en Farmacia, Servicios sanitarios/Ciencias de la salud, general -
Universidad de Granada
Grado en Farmacia, Servicios sanitarios/Ciencias de la salud, general -
IES Puerta de Arenas
Bachelor's degree, Servicios sanitarios/Ciencias de la salud, general