Summary
Overview
Work History
Education
Skills
Affiliations
Timeline
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Minette Reyes

Quality & Regulatory Affairs Leader
City Of Sta. Rosa

Summary

Accomplished regulatory affairs leader with a proven track record in the healthcare industry. Excels in strategic regulatory project management and quality assurance. Skilled in fostering cross-functional team collaboration and innovation, with expertise in training and mentoring. Demonstrated ability to enhance compliance and streamline processes, significantly contributing to corporate goals.

Overview

28
28
years of professional experience
1997
1997
years of post-secondary education

Work History

Quality & Regulatory Affairs Leader

Roche Philippines, Inc.
04.2023 - 03.2025
  • Company Overview: Diagnostic Division
  • Lead the oversees development and execution of regulatory strategies, regulatory projects, regulatory submissions and associated activities to ensure rapid and optimal registration for all new products and indications, as well as line extensions and ensuring the effective and compliant regulatory maintenance of existing products.
  • Acts as the Affiliate Quality Head (AQH), Deputy Local Safety Officer (LSO) for Diagnostics, and Deputy Local Regulatory Safety Officer (LRSO) for Diabetes Care.
  • Led cross-functional teams to achieve company-wide goals, fostering a culture of collaboration and innovation.
  • Regulatory Intelligence lead in providing information and interpretation regarding regulatory requirements to the Global Regulatory Submission Affiliate Coordinator and BA/BU function heads to develop regulatory strategy clearance plans and regulatory opinions.
  • Diagnostic Division

Regulatory Affairs Manager

Zuellig Pharma Therapeutics
01.2022 - 03.2023
  • Kept abreast of evolving industry trends, allowing the company to adapt quickly to changes in the regulatory landscape.
  • Prepared and maintained document inventory for core dossier preparation.
  • Manage the planning and execution of all activities necessary for the registration of new products and all products related application of MDIT and ZPC.
  • Develop, implement and oversee activities involved in assuring compliance with the appropriate rules and regulations and to meet the regulatory reporting requirement set by the FDA.
  • Ensure the appropriate licensing, marketing and legal compliance of pharmaceutical and veterinary products in order to control the safety and efficacy of products.

Corporate Pharma Head

Actimed Inc.
10.2019 - 12.2021
  • Spearheading both the Actimed Distribution Center and the Generika Drugstores Branches complies with all FDA regulatory requirements and quality standards impacting the business operations.
  • Ensure that all the products comply with the appropriate licensing, marketing and legal compliance in order to control the quality, safety and efficacy of products sold in Generika Drugstores branches.
  • Act as Network Management and is responsible for establishing, maintaining, and enhancing effective relationships with FDA regulatory and key officers, pharmaceutical companies and related organizations.
  • Interpret and effectively deal with complex regulatory and quality issues across business units in support of local and corporate goals.
  • Demonstrated strong organizational and time management skills while managing multiple projects.

Regulatory Affairs Manager

Metro Drug, Inc.
09.2014 - 10.2019
  • Prepared and maintained document inventory for core dossier preparation.
  • Collaborated with cross-functional teams to ensure alignment on regulatory requirements and timelines.
  • Developed strong relationships with key stakeholders, facilitating open communication channels between organizations.
  • Spearheaded training initiatives for staff on regulatory affairs topics, promoting a culture of continuous learning.
  • Actively participated in industry conferences and workshops, enhancing professional networks while staying up-to-date on best practices in regulatory affairs management.

Regulatory Affairs Consultant

Metro Drug Inc.
03.2012 - 08.2014
  • Mentored junior team members, providing guidance on best practices in regulatory affairs and fostering professional growth.
  • Maintained thorough records of regulatory correspondence, ensuring easy access to critical information during audits and inspections.
  • Managed complex regulatory projects, consistently meeting critical deadlines and budget constraints.
  • Served as a subject matter expert during meetings with clients and partners, confidently representing the company's regulatory expertise.

Regulatory Affairs Consultant

Euromed Laboratories, Philippines
03.2010 - 12.2012
  • Managed complex regulatory projects, consistently meeting critical deadlines and budget constraints.
  • Established strong relationships with key stakeholders at regulatory agencies, fostering open communication channels for prompt issue resolution.
  • Served as a subject matter expert during meetings with clients and partners, confidently representing the company's regulatory expertise.
  • Prepared and submitted regulatory file applications and supporting documentation.

Regulatory Affairs Manager

La Croesus Pharma, Inc.
04.2009 - 03.2010
  • Performed and documented quality control checks to maintain compliance with company initiatives.
  • Prioritized project-related tasks to efficiently complete essential tasks.
  • Enhanced regulatory compliance by developing and implementing effective policies and procedures.
  • Oversaw timely preparation and submission of high-quality documentation for product registrations and renewals.
  • Evaluated emerging legislation and its potential impact on current products or future developments.
  • Managed fees and applications, tracked product progress and handled all responses to regulatory inquiries.

Regulatory Affairs Supervisor

Servier Philippines, Inc.
08.2008 - 02.2009
  • Prepared and maintained document inventory for core dossier preparation.
  • Oversaw timely preparation and submission of high-quality documentation for product registrations and renewals.
  • Monitored competitor activities within the industry landscape, informing strategic decision-making processes accordingly.
  • Worked with internal team members to accomplish regulatory goals and achieve full compliance with all products.

Regulatory Affairs Supervisor

Metro Drug Inc.
04.2005 - 08.2008
  • Collaborated with cross-functional teams to ensure alignment on regulatory requirements and timelines.
  • Enhanced regulatory compliance by developing and implementing effective policies and procedures.
  • Evaluated emerging legislation and its potential impact on current products or future developments.
  • Streamlined submission processes for improved efficiency and timely approvals from regulatory agencies.
  • Actively participated in industry conferences and workshops, enhancing professional networks while staying up-to-date on best practices in regulatory affairs management.

Stock Analyst

Excelmed Solutions, Inc.
02.2003 - 01.2005
  • Company Overview: (a Division of Unilab)
  • Analyze stock movement; records and monitors deliveries and issuances; and inventory management.
  • Conducts stock movement to evaluate items that are fast or slow moving and monitors stock inventory for timely replenishment of items.
  • Prepares inventory report required by the management.
  • (a Division of Unilab)

Officer in Charge- Pharmacy Department

Dr. Fe Del Mundo Medical Center Foundation Phil.
06.2000 - 04.2002
  • Plans, organizes and supervises the Hospital Pharmacy in accordance with the hospital policies, standard practice of the profession as well as government laws, rules and regulation.
  • Handled administrative requirements, maintained records and submitted operational reports.
  • Developed comprehensive training programs tailored to individual skill sets, resulting in increased proficiency among personnel.
  • Led team in developing strategic plans to meet operational objectives.

College Instructor (Pharmacy Department)

Centro Escolar University
11.1996 - 03.1999
  • Enhanced student comprehension by utilizing a variety of teaching methods, including lectures, discussions, and group activities.
  • Developed semester outlines and instructional plans for each class session to comply with stated course objectives.
  • Graded quizzes, tests, homework, and projects to provide students with timely academic progress information and feedback.
  • Reviewed program materials and coordinated updates to keep department materials relevant and accurate.

Education

Bachelor of Science - Pharmacy

Centro Escolar University
Manila, Metro Manila

Skills

  • Coaching and guidance
  • Effective priority management
  • Organizational strategy development
  • Strategic decision-making
  • Process optimization
  • Team motivation
  • Collaborative networking abilities

Affiliations

  • Philippine Association of Medical Regulatory Affairs Professional (PAMDRAP), Assistant Treasurer, 2023-2025
  • CEU- Alumni Foundation Inc., Vice President, 2024-2026

Timeline

Quality & Regulatory Affairs Leader

Roche Philippines, Inc.
04.2023 - 03.2025

Regulatory Affairs Manager

Zuellig Pharma Therapeutics
01.2022 - 03.2023

Corporate Pharma Head

Actimed Inc.
10.2019 - 12.2021

Regulatory Affairs Manager

Metro Drug, Inc.
09.2014 - 10.2019

Regulatory Affairs Consultant

Metro Drug Inc.
03.2012 - 08.2014

Regulatory Affairs Consultant

Euromed Laboratories, Philippines
03.2010 - 12.2012

Regulatory Affairs Manager

La Croesus Pharma, Inc.
04.2009 - 03.2010

Regulatory Affairs Supervisor

Servier Philippines, Inc.
08.2008 - 02.2009

Regulatory Affairs Supervisor

Metro Drug Inc.
04.2005 - 08.2008

Stock Analyst

Excelmed Solutions, Inc.
02.2003 - 01.2005

Officer in Charge- Pharmacy Department

Dr. Fe Del Mundo Medical Center Foundation Phil.
06.2000 - 04.2002

College Instructor (Pharmacy Department)

Centro Escolar University
11.1996 - 03.1999

Bachelor of Science - Pharmacy

Centro Escolar University

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Minette ReyesQuality & Regulatory Affairs Leader