Zaira Custodio
Registered Pharmacist
Muntilupa City
Summary
Well-organized and diligent Regulatory Affairs Specialist adept at coordinating and tracking regulatory-related actions. Highly successful at keeping on top of changes in requirements to maintain flawless compliance. Offering years of experience in the regulatory industry and looking for a challenging new role.
Overview
17
17
years of professional experience
4
4
years of post-secondary education
1
1
Certification
Work History
Freelance Regulatory Affairs Officer
Various companies
10.2021 - 07.2022
- Increased customer satisfaction by resolving issues.
- Resolved problems, improved operations and provided exceptional service.
- Resolved conflicts and negotiated mutually beneficial agreements between FDA and companies.
- Reviews documents provided by principals for product registration, ensuring safety and efficacy of the products in accordance with FDA regulations prior to trade release.
Regulatory Affairs Associate
DTG Medical Inc.
Taguig City
05.2021 - 01.2022
- Prepared and submitted regulatory file applications and supporting documentation.
- Interpreted regulatory rules and monitored communication through corporate policies and procedures.
- Collaborates with in-country and above-country stakeholders in the development and implementation of strategies to meet regulatory submissions and approvals, mitigate supply risks and address compliance issues.
- Contributes to change management and continuous improvement projects.
- Developed recommendations for storage conditions to assure product quality objectives and met product specifications.
- Evaluated workplace conformance with government standards and regulations, implementing immediate strategies to resolve deficiencies.
- Performed and documented quality control checks to maintain compliance with company initiatives.
- Analyzed product complaints and made recommendations regarding reportability.
Operations Supervisor
Reed Elsevier Philippines
Quezon City
09.2020 - 03.2021
- Responsible for managing Elsevier’s drug information data systems.
- Manages and directs Philippine based Elsevier US Drug Information Content team.
- Motivated and trained employees to maximize team productivity.
- Monitors the efficacy and improves the operating process of the Drug Information
Content team. - Manages the development, implementation and enhancement of operating policies, processes and procedures that affects Elsevier’s long term and short term goals, and strategies.
- Plans and coordinates operations and special projects in multiple areas, joint venture,
business and development, internal communications, and budgeting.
Regulatory Pharmacist
Rustan Commercial Corporation
Makati City
05.2009 - 12.2019
- Assures that all necessary documents for product registration are clear and complete prior to introduction to the government regulating body for approval.
- Creates and amends registration dossiers as necessary for local and regional requirements for submission to the regulatory authorities.
- Reviews documents provided by principals for product registration, ensuring safety and efficacy of the products (mainly cosmetics, household hazardous
substances, medical devices and food supplements) in accordance with FDA regulations prior to trade release. - Monitors, collects and interprets regulatory issues and trends that will impact our
products, policies and procedures. - Issues certificates of fragrance importation for Bureau of Customs.
- Communicates with the Foreign Principals in collecting all necessary registration documents.
- Responsible for proper safekeeping of all confidential documents (product formulation, specification, safety assessments, etc) related to product registration.
- Interface with government agencies and industry associations to assess the impact and implementation of required company compliance with all regulations, laws and industry policies that affect the ingredients, packaging, marketing, advertising, and labeling the products.
- Develops and maintains a close personal and business relationship with key figures at the Food and Drug Administration.
- Assures that the company’s operations comply with FDA regulations.
- Develops process & procedures for document control and proper workflow for the office of regulatory affairs.
Company Pharmacist/Quality Assurance Analyst
Kino Consumer Philippines Inc.
Makati City
11.2005 - 05.2009
- Assures that all necessary documents for product registration (food and cosmetics) are clear and complete prior to introduction to the government
regulating body for approval. - Monitors, collects and interprets regulatory issues and trends that will impact company products, policies and procedures.
- Assures that the company’s operations comply with the Food and Drug Administration.
- Interface with government agencies and industry associations to assess the impact and implementation of required company compliance with all regulations,
laws and industry policies that affect the ingredients, packaging, marketing, advertising, labeling of products. - Develops and maintains a close personal and business relationship with key figures at the Food and Drug Administration.
- Compile and maintain a database of the regulatory status for all regulated products, including those projects still in the process of regulatory approval.
- Develop Quality Systems to drive process improvement, maintain best product quality, improve operational efficiency and generate savings.
- Organize internal audits of manufacturing sites and monitor audits performed by 3rd Parties.
- Provide regulatory and product expertise in the development and clearance of advertising and label copy for existing and new products in the market. Maintain the filing of approved artwork and advertising copy.
- Supervises and coordinates activities of all QA Inspectors who perform QA tasks such as sampling, inspections, and tests designed to ensure manufactured products comply with internal SOPs, safety initiatives, and company policies.
- In-charge in managing tasks related to manufacturing processes and quality assurance.
- Investigate failures and deviations in manufacturing operations and initiate corrective action.
- Coordinates with Kino-Indonesia (head office) in terms of product development, product quality, and in-process manufacturing.
Pharmacist
Generika Drugstore
Muntinlupa City
09.2004 - 07.2005
- Recommended OTC devices or medication options to help mitigate individual symptoms.
- Interpreted prescription orders, dispensed medications and counseled patients on drugs.
- Maintained appropriate drug records and completed reports as necessary.
- Reviewed and evaluated orders for non-formulary to identify generic alternatives.
- Handles 5 pharmacy assistants.
Education
Bachelor of Science - Pharmacy
Centro Escolar University
Manila, Philippines 06.2000 - 04.2004
Skills
Qualified Person in Regulatory Affairs for Drugs, Medical Devices, Cosmetics, Household Hazardous, and Food
Certification
Pharmacy Licensure Exam
Timeline
Freelance Regulatory Affairs Officer
Various companies
10.2021 - 07.2022
Regulatory Affairs Associate
DTG Medical Inc.
05.2021 - 01.2022
Operations Supervisor
Reed Elsevier Philippines
09.2020 - 03.2021
Regulatory Pharmacist
Rustan Commercial Corporation
05.2009 - 12.2019
Company Pharmacist/Quality Assurance Analyst
Kino Consumer Philippines Inc.
11.2005 - 05.2009
Pharmacist
Generika Drugstore
09.2004 - 07.2005
Pharmacy Licensure Exam
07-2004
Bachelor of Science - Pharmacy
Centro Escolar University
06.2000 - 04.2004
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