Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

JOANA MARIELLE PALMES

Manila, Metro Manila

Summary

Regulatory professional prepared for role demanding meticulous attention to compliance and regulatory standards. Expertise in managing regulatory submissions and maintaining thorough documentation. Known for effective teamwork and adaptability in dynamic environments. Proven ability to interpret regulatory guidelines and communicate effectively with stakeholders.

Overview

9
9
years of professional experience
1
1
Certification

Work History

Regulatory Affairs Associate

AMB HK ENTERPRISES, INC.
10.2024 - Current
  • Manage Initial applications, Renewals, and Foreign GMP Inspection requests, including responses to FDA-issued Notices of Inspection (NOI).
  • Prepare and submit major/minor variations and post-approval notifications in compliance with regulatory requirements - FDA Philippines requirements.
  • Conduct Pharmaceutical Warehouse audits for client facilities and support FDA audit preparedness and compliance activities.
  • Oversee the renewal of Certificates of Product Registration (CPRs), Principal Certificate of Product Registration (PCPR), and Certificate of Listing of Identical Drug Product (CLIDP).
  • Draft and update Standard Operating Procedures (SOP's) in line with the GMP, GDP and GSP standards to ensure ongoing regulatory compliance.
  • Coordinate with internal teams and regulatory authorities to ensure timely and accurate submissions and adherence to applicable laws and guidelines.

Clinical Research Associate II

Novotech (Australia) Pty. Ltd.
01.2023 - 07.2024
  • Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
  • Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
  • Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
  • Implemented electronic data capturing systems to adhere with clinical research guidelines.
  • Supported the successful completion of clinical trials by proactively managing risks and addressing challenges throughout all stages of the study process.
  • Conducted clinical trial in accordance with protocol and recorded and monitored progress.
  • Facilitated timely resolution of issues through effective communication with investigators, sponsors, and other stakeholders.
  • Enhanced data quality by closely monitoring study progress and ensuring accurate data collection.
  • Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.


Clinical Research Associate I

Tigermed Services Philippines Inc.
02.2022 - 01.2023
  • Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
  • Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
  • Ensured protocol adherence, conducting regular site visits and providing training to study staff as needed.
  • Reviewed data queries and listings and worked with study centers to resolve data discrepancies.
  • Followed drug storage procedures to comply with protocols and SOP requirements.
  • Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
  • Assessed safety reporting requirements for each study, ensuring proper documentation and notification procedures were followed consistently.

Sr. Reference File Maintainer

IQVIA Solutions Philippines
06.2020 - 02.2022
  • Self-motivated, with a strong sense of personal responsibility.
  • Worked effectively in fast-paced environments.
  • Skilled at working independently and collaboratively in a team environment.
  • Proven ability to learn quickly and adapt to new situations.
  • Worked flexible hours across night, weekend, and holiday shifts.
  • Managed time efficiently in order to complete all tasks within deadlines.
  • Assisted with day-to-day operations, working efficiently and productively with all team members.

Regulatory Affairs Associate

DermPharma, Inc.
09.2019 - 06.2020
  • Coordinated responses to FDA deficiency letters, addressing concerns promptly and professionally while minimizing disruption to ongoing projects.
  • Act as Company Pharmacist of JLC Miller & Co., Inc.; Attends FDA inspections as qualified personnel. Monitors, maintains and ensures that the License to Operate (LTO) as Drug Wholesaler, Cosmetic Wholesaler and Food Wholesaler are up to date.
  • Kept up-to-date with changes in regulatory legislation and guidelines and obtained marketing permissions.
  • Enhanced regulatory compliance by meticulously reviewing and editing submission documents.
  • Provided guidance to team members on regulatory requirements, promoting a culture of compliance within the organization.
  • Monitored industry trends and regulatory updates, maintaining a strong understanding of current best practices in the field.
  • Assisted in developing effective strategies for addressing FDA inquiries, leading to faster resolution times.

Regulatory Affairs Associate

Crisdy-Na Drug Corp.
02.2019 - 07.2019
  • Interpreted regulatory rules or rule changes and monitored communication through corporate policies and procedures.
  • Worked closely with quality assurance teams to identify potential risks and implement corrective actions, ensuring compliance with regulatory requirements at all stages of product development.
  • Streamlined regulatory processes for increased efficiency in submitting drug applications to the FDA.
  • Maintained and archived regulatory paperwork.
  • Prepared and submitted regulatory file applications and supporting documentation.
  • Review Packaging Materials Artwork and ensure details are align within FDA guidelines.

Pharmacist In Charge (Product Development Dept.)

Hizon Laboratories Inc.
02.2017 - 02.2019
  • Formulate new out- of-patent generic drug generic drug products and customized formulations based on specific client requirements.
  • Conducts pilot batch production for FDA registration, product development, and stability studies in compliance with current Good Manufacturing Practices (cGMP).
  • Prepares comprehensive documentation for initial product registration, including regulatory dossiers such as ACTD and Biowaiver submissions.
  • Supervises pilot first commercial batch productions, ensuring adherence to approved formulations and manufacturing protocols.
  • Dispenses raw materials in accordance with Batch Manufacturing Records (BMRs) and ensure proper reconciliation.
  • Complete, reviews, and maintains accurate BMRs for all pilot batches; oversees systematic filing and documentation control.

Education

Pharmacy

Adamson University
Ermita, Metro Manila, Philippines
04-2015

Skills

  • Efficient submission organization
  • Compliance relationship management
  • ICH guideline adherence
  • Compliance with clinical standards
  • Safety documentation
  • Effective manufacturing practices
  • Teamwork and collaboration
  • Problem-solving
  • Reliability
  • Multitasking Abilities
  • Critical thinking
  • Experience in using EDC systems such as Imedidata,cubeCDMS, Riehen Clinical Trial EDCS, Viedoc and Clinflash along with CTMS, Veeva and Irton for IP management and randomization system

Certification

  • GOOD DISTRIBUTION AND STORAGE PRACTICE FOR MEDICAL PRODUCTS (FOR DRUG DISTRIBUTORS) Training - 18 JULY 2025
  • Licensed Pharmacist - 2016

Timeline

Regulatory Affairs Associate

AMB HK ENTERPRISES, INC.
10.2024 - Current

Clinical Research Associate II

Novotech (Australia) Pty. Ltd.
01.2023 - 07.2024

Clinical Research Associate I

Tigermed Services Philippines Inc.
02.2022 - 01.2023

Sr. Reference File Maintainer

IQVIA Solutions Philippines
06.2020 - 02.2022

Regulatory Affairs Associate

DermPharma, Inc.
09.2019 - 06.2020

Regulatory Affairs Associate

Crisdy-Na Drug Corp.
02.2019 - 07.2019

Pharmacist In Charge (Product Development Dept.)

Hizon Laboratories Inc.
02.2017 - 02.2019

Pharmacy

Adamson University

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