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Graciel R. — Mid-Level Regulatory Affairs Manager from Dominican Republic

Graciel R.

Mid-Level Regulatory Affairs Manager

Dominican Republic 6+ years
Open to offersNew to Platform
Languages
Spanish
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About

Graciel R. is a licensed pharmacist with extensive experience in quality control, regulatory affairs, and pharmaceutical management. She currently serves as the Head of Regulatory Affairs at Fármaco Quimica Nacional, where she's responsible for preparing dossiers for sanitary registration with the Ministry of Public Health, supervising subsidiary managers, and ensuring the proper functioning of quality controls. Previously, she was the Quality Assurance Coordinator at Asofarma Rep. Dom.-Leterago SRL, overseeing documentation and quality practices, conducting internal audits, and training personnel. Graciel's career began as a Quality Control Analyst at Laboratorio Magnachem S.R.L. and Laboratorios Feltrex S.A., where she conducted sampling and analysis of raw materials and finished products. Her role involved comprehensive inspections across various pharmaceutical production areas. Additionally, she has completed specialised training in regulatory affairs and Good Manufacturing Practices, enhancing her proficiency in Microsoft Office and internal auditing.

Experience

  • Regulatory Affairs Manager

    Fármaco Quimica Nacional · 2016 — Present
    Responsible for preparing dossiers for sanitary registration with the Ministry of Public Health, following up on submitted documentation, obtaining and maintaining sanitary authorizations, and fostering good relationships with regulatory agencies in other countries. Supervised branch managers and ensured quality control compliance throughout the branches, in addition to developing Standard Operating Procedures (SOPs).

  • Quality Assurance Coordinator

    Asofarma Rep. Dom.-Leterago SRL · 2013 — 2015
    Tasked with planning, coordinating, and ensuring the documentation related to Quality Assurance activities for company products, while overseeing good distribution practices. Conducted internal audits of local and Central American logistics distributors and trained all company personnel. Organized emergency mock confiscation drills and handled the release of cold chain products for commercialization, while also assisting the regulatory area with dossier preparation for sanitary registration. Supervised the medical sample storage and managed deviation reports by claims, along with conducting regular visits to distributors.

  • Quality Control Analyst

    Laboratorios Feltrex S. A. · 2011 — 2013
    Conducted sampling and analysis of raw materials and finished products, including stability testing. Inspected production operators and provided regulatory support in preparing dossiers for sanitary registration, in addition to performing microbiological testing of water and validating finished products.

  • Quality Control Analyst

    Laboratorio Magnachem S.R.L. · 2009 — 2011
    Performed analysis and sampling of raw materials, and handled sanitary registration for pharmaceutical products. Conducted stability tests and finished product analysis while serving as an inspector in various areas including liquids, parenterals, antibiotics, cefalosporins, and packaging materials.

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