Registered and licensed pharmacist (RPh) in Philippines since year 2001.
Experienced professional equipped with skills in the field of Regulatory, Pharmacovigilance, Clinical Practice, Good Manufacturing Practice, Quality Assurance and Safety
In-depth knowledge of the ASEAN Regulatory Requirements in the registration of pharmaceuticals, food, food supplements, traditional medicines, cosmetics and medical devices, marketing authorization and licenses.
Worked with the Philippine Food and Drug Administration (FDA) to evaluate pharmaceutical dossiers and make recommendations as to acceptability for marketing authorization.
Pharmacist License from Philippines
License No. 45906
Competent, organized and results-oriented
Flexible, team player and can work well in a high pressure environment
Articulate and creative, offering practical solutions
Committed to assisting others and able to recognize client needs
Excellent written and verbal communication skills
basic computer skills (MS Word, MS Excel MS Power Point and MS Outlook), and can quickly learn new software
United Laboratories, Inc.July 2008 to December 2016Regulatory Affairs Officer Pasig, Manila, Philippines
* Evaluated and prepared product registration dossiers for submission to Philippine Food and Drug Administration and health authorities in different countries like Singapore, Hongkong, Myanmar, Dubai, Ghana and others.
* Reviewed food and drug product information to be reflected in the patient information leaflet, package inserts, and other labeling materials
* Liaised to represent the company by visiting the regulatory authority to conduct follow-up and queries regarding product applications
* Successfully secured products' marketing authorization and licenses within the set timeline
* Provided reliable and accurate information and coordinated with Medical Affairs, Research & Development, Quality Control, Quality Assurance, Warehouse, Business Development Group and other departments in the organization when consulted regarding regulatory requirements, policy and guidelines
* Attended and assisted the department head in conducting research and collecting written updates relating to FDA updates
* Regularly updated our immediate superior and division head on the accomplishments done and pending tasks through monthly operations report
* Effective and enthusiastic team leader to two (2) regulatory affairs specialists
Daewoong Pharma Philippines, Inc.December 2007 to July 2008Regulatory Affairs Manager Pasig, Manila, Philippines
* Responsible for the day-to-day operations of the Company's Regulatory Affairs with specific emphasis on the preparation, review, and evaluation of documents for submission to regulatory authorities.
* Handled product registration of food supplements, pharmaceuticals, cosmetics and medical devices to Philippine Food and Drug Administration.
* Assisted the Marketing Department on the different strategy fit for the Philippine pharmaceutical setting
* Coordinated and communicated with the Daewoong Pharmaceutical Co., Ltd. Global Team regarding updates of issuances, guidelines and requirements on product registration issued by FDA and other regulatory agencies.
Bureau of Food and Drugs (currently Food and Drug Administration)November 2001 to December 2007Pharmacist - Drug Evaluator / Food and Drug Regulation Officer Muntinlupa, Philippines
* Evaluated technical information of multisource (generic) products recognized in any pharmacopoeia submitted by a drug manufacturer/trader/importer/distributor and made recommendations as to acceptability for registration.
* Entertained follow-ups in product applications, telephone queries, among others
* Assisted in continuing research and updating scientific product evaluation techniques
* Assessed and reviewed applications submitted by clients / pharmaceutical companies in ACTD format
* Conducted inspection with the Licensing Division personnels to check current Good Manufacturing Practice of establishments
* Maintained record management and database for registered products
Education and Training
University of Sto. Tomas2001Bachelor of Science: PharmacyManila, Philippines