Experience

Interfarma Corp

• United States
• Packaging and Containers Manufacturing

• Regulatory Affairs Specialist

  • Dec 2013 - Present

  • Coordinate and prepare document packages for submission to regulatory agencies in Latin-American countries • Recommend revisions for labeling, manufacturing, marketing documentation, and procedures • Maintain contact with Health Entities in Latin American to keep track of ongoing processes. • Compile all materials required for submissions, license renewals, variations and annual registrations • Collaborate with regulatory agencies and recommend strategies for expedited approvals • Provide regulatory support with corresponding legal documentation (CPP's, GMP's certificates) dully legalized by Apostille and/or Consulate certifications; including technical regulatory documents (Certificates of Analysis, Material Safety Data Sheets, Specifications, Product Labels, Samples of the Active ingredient, Reference Substance, Product Registration Documents, Technical Literature) • Maintain proprietary corporate database of QC and Regulatory information including Certificates of Analysis, Material Safety Data Sheets, Specification sheets for pharmaceutical chemicals, and raw materials to assure customers receive all required documentation • Complete dossiers to support re-registrations due to internal or external changes or renewals; expedition and notification to registration agents; tracking mailing activities to ensure receipt of documents and registration materials Show less



Quimefa

• Spain
• Appliances, Electrical, and Electronics Manufacturing

• Specialist

  • Nov 2007 - Apr 2012

  • Setup and configured an inventory system (Mistral by Taylor) in main pharmaceutical laboratories to control raw materials, packaging, used for manufacturing generic drugs. • Evaluated and reported test results for review by management team. • Maintained an organized, safe and efficient work area at all times. • Supervised material flow, storage and global order fulfillment. • Setup and configured an inventory system (Mistral by Taylor) in main pharmaceutical laboratories to control raw materials, packaging, used for manufacturing generic drugs. • Evaluated and reported test results for review by management team. • Maintained an organized, safe and efficient work area at all times. • Supervised material flow, storage and global order fulfillment.



CEINPET

• Cuba
• Wholesale Petroleum and Petroleum Products

• Analytical Chemist

  • Sep 2002 - Oct 2007

  • Carried out R&D work related for the characterization of crude oils and their derivatives. • Operational knowledge of analytical instrumentation like HPLC, GC, FTIR, UV-VIS equipment, and data stations required. • Prepared samples, standards, mobile phases and diluents according to specific procedures. • Analyze and interpret chromatography to determine to the active peak meets all specifications and that no impurities were present. • Applied instrumental techniques to determine physical and chemical properties of average oil derivatives. • Setup and maintained current, precise and systematic records and lab notebooks in accordance with existing guidelines and maintained data archives and samples. • Conducted calibration, qualification and maintenance of laboratory instrumentation. • Calibrated and maintained all laboratory equipment, including spectrometers and chromatographs. Show less