MARIA CECILIA ATIENZA LIBANG, RPh

Dynamic regulatory affairs professional with extensive expertise in navigating complex regulatory landscapes and ensuring compliance. Proven success in driving timely submissions and securing approvals for critical projects while fostering collaborative team environments and adapting to evolving regulatory demands. Committed to delivering exceptional results and upholding the highest standards of quality and integrity. Demonstrated ability to foster innovation and efficiency within regulatory processes, contributing to organizational success.

• Regulation of Over-the-Counter (OTC), Traditional and Herbal Medicine, and Medical Oxygen – April 19, 2023
• Guidelines on Ads and Sale Promotion, and Securing BOC Clearance – March 22, 2023
• Pharmaceutical Product Registration - Labelling Guidelines and Its Relationship to Ads and Promo – March 14, 2023
• PIC/S GMP Guide PE009-14 Current Regulatory Requirements – Nov 22-24, 2022
• Technical Requirements and Procedures for E-Registration of all Processed Food Products – October 04, 2022
• Licensing Seminar for Cosmetics, Toys, and Child Care Articles, and Household/Urban Pesticides Establishments – September 28, 2022
• Licensing Seminar for Drug Establishment – September 07, 2022
• Pharmacovigilance 101 – August 10, 2022
• Overview of the Philippine Mandatory Labeling Guidelines – June 16, 2022
• Pharmaceutical Product Registration – Bioavailability/Bioequivalence – June 28, 2022
• Pharmaceutical Product Registration – Stability Guideline – May 31, 2022
• Good Distribution and Storage Practice for Drug Products (For Drugstores, Hospital Pharmacy, and Drug Distributor) – May 26, 2022
• Introduction to Pharmaceutical Registration – May 17, 2022

• Lead the preparation, review, and submission of regulatory dossier for product registrations, variations, and renewals.
• Act as the primary liaison with the FDA and other health authorities, ensuring timely responses and positive relationship.
• Monitor evolving regulatory guidelines and communicate their impact to internal stakeholders.
• Provide regulatory guidance to R&D, Quality, Supply Chain, Marketing, and Medical Affairs.
• Ensures all product labeling, promotional materials, and packaging meet all regulatory requirements.
• Collaborate across departments to integrate regulatory strategies into product development and lifecycle management.
• Drive regulatory strategy for assigned products to achieve timely approvals.
• Ensure product registrations are maintained and renewed without disruption.
• Participate in audits and inspections, ensuring compliance with both local and international standards.

• Pharmacy Board Exam Passer
• Philippine Professional Regulation Commission, Board of Pharmacy
• January 2008

Dr. Philip Nakpil,  Medical Affairs Director, +639209521227