Sr Regulatory Affairs Lead Consultant - DS Cosmeceuticals Mfg. Laboratory - Laguna City, Philippines
(2026-01)
Regulatory Affairs Manager (Contract Position) - Exeltis International Philippines Inc. - 6750 Ayala Avenue Office Tower, Makati City, Philippines
(2025-06 - 2025-12)
- Spearheaded comprehensive product registration activities, including new product applications, while monitoring release, renewals, post-approval variations, and promotional permits to ensure timely submissions and approvals within established timelines.
- Orchestrated the Long Term Plan (LTP) for the company's regulatory activities related to product registration, effectively coordinating with the head office and conducting thorough reviews of dossiers, applications, and submissions to the FDA to facilitate new launches.
- Ensured the validity of Certificate of Product Registrations while maintaining the GMP Clearance Certificate.
- Managed both PH and Global license databases to remain compliant with GDP standards.
- Facilitated new product launches by securing prompt approvals from relevant authorities.
- Collaborated with the headquarters in Madrid, Spain to ensure adherence to GMP, initial registration, and labeling requirements.
- Supervised the implementation of FDA regulations.
- Supported Business Development, Marketing, and General/Country Manager Projects, acting as a liaison with GS1 PH regarding product barcodes.
- Directed the Regulatory Team in filing applications with the FDA Philippines, providing essential product information for both internal and external inquiries.
- Collaborated with official publications (MIMS, PPD, etc.) to ensure regulatory compliance, and prepared labeling and leaflets that met regulatory standards.
- Delivered training and technical support to sales and marketing teams, thoroughly reviewing marketing materials to ensure FDA-approved claims.
- Coordinated with distributor partners (In-License and Out-License), manufacturers, and QA on compliance matters.
- Ensured compliance with waste management standards and completed mandatory training via MyLearnSpace.
- Maintained updated forms in On-Base and tracked MA status (READY!). Managed complaints, CAPA, and inquiries through Trackwise.
- Updated the Regulatory tracker, QAAs, QTAs, and Registration Agreements; coordinated with Global Quality & Compliance on regulatory initiatives.
- Handled and documented ADRs/complaints, escalating unusual or litigious cases to HQ, monitoring ADR/ADE, detecting signals, and tracking consumer feedback.
- Ensured product safety by meticulously monitoring the benefit-risk profile and analyzing effectiveness, communicating with the FDA on safety concerns and reporting mechanisms.
- Maintained pharmacovigilance SOPs and protocols, conducted safety analyses, and signal detection, participating in pharmacovigilance inspections and audits.
- Conducted training for employees on pharmacovigilance procedures and regulations, and reviewed clinical protocols, safety reports, and scientific literature, updating labels with new safety information as necessary.
- Served as the Local Contact Person for pharmacovigilance in the Philippines, acting as the primary FDA contact.
Regulatory Affairs Manager - Glenmark Philippines, Inc. - 11th Avenue, Bonifacio Global City, Taguig City, Philippines
(2021-10 - 2025-04)
- Led the Regulatory Affairs team, successfully contributing to mapping the regulatory landscape while defining Glenmark's strategic approval and maintenance strategy for the Philippines.
- Managed initial product filings and approvals, maintained LTO/CPR/GMP, reviewed labeling and promotional materials, ensured regulatory compliance, and oversaw the full regulatory lifecycle.
- Prepared and submitted comprehensive regulatory dossiers, enhancing overall submission efficiency.
- Coordinated regulatory document submissions with partners and headquarters, critically reviewing labeling and promotional materials for compliance.
- Ensured adherence to regulatory requirements throughout the entire regulatory process.
- Devised strategic regulatory approaches to support new filings, pending applications, and approved applications, aligning them effectively with business objectives.
- Represented the company and fostered productive relationships with Health Authorities, along with In-Licensing and Out-Licensing partners.
- Facilitated the processing of the Product Grid for the country while managing all regulatory processes and interfaces linked to its operations.
- Collaborated with cross-functional teams (Business Development, Marketing, Country Manager) to support business launches.
- Served effectively as the Deputy Pharmacovigilance Officer, providing oversight and support for pharmacovigilance initiatives.
- Provided training and coaching to the regulatory team while overseeing updates and advancements in regulatory activities.
Regulatory Affairs Manager - Luoxin Pharmaceuticals Corp. (Chinese Pharmaceutical) - Taguig City - Davao City, Philippines (Hybrid)
(2019-07 - 2021-10)
- Established regulatory frameworks for the company by securing Luoxin Pharma's initial License to Operate (LTO), facilitating the setup of regulatory presence in the Philippines and supporting subsequent product registrations and compliance activities.
- Oversaw regulatory submissions, new drug applications, and variations, ensuring efficient timelines to mitigate delays in the approval process.
- Conducted quality assurance assessments of regulatory submissions for compliance, accuracy, and timeliness, while maintaining organized documentation for licenses and registrations.
- Directed compliance oversight to ensure alignment with FDA regulations, effectively addressing inquiries and deficiencies raised by authorities.
- Acted as the company's representative with regulatory bodies (FDA, IPO), supporting audits and inspections with comprehensive documentation and process adherence.
- Collaborated with upper management to align regulatory objectives with the company's vision, assisting sales and marketing teams with compliance documentation as necessary.
- Led regulatory teams, providing instruction, delegating tasks, and implementing standard operating procedures (SOPs) to enhance team performance.
Senior Regulatory Affairs Lead - Baxter Inc (formerly Claris Lifescience Inc.) - 98 V.A. Rufino St. cor. Valero St., Salcedo, Makati City, Philippines
(2017-06 - 2019-07)
- Oversaw compliance with FDA regulations by managing product submissions (e.g., initial, renewal, variation, LTO), labeling materials, promotional permits, and pharmacovigilance efforts, ensuring full compliance and timely approvals in line with regulatory standards.
- Managed trademark registrations with the Intellectual Property Office, overseeing renewals and pending cases.
- Secured necessary permits for Dangerous Drugs (DD) through effective coordination with PDEA, while monitoring shipments and managing inspections and recalls in adherence to PDEA regulations.
- Acted as Pollution Control Officer for DENR compliance, overseeing permits and the destruction of expired products in a timely and efficient manner.
- Collaborated closely with executives on annual budgetary planning, regulatory updates, and strategic initiatives, supporting product promotions and addressing technical inquiries at industry conventions effectively.
- Trained staff and reviewed SOPs, maintaining streamlined regulatory processes across various organizations, including FDA, PDEA, DENR, and IPO, enhancing regulatory compliance culture.
Senior Regulatory Publishing - Pfizer Inc (under ImedGlobal) - Fort Legend Tower, 31st Avenue, Bonifacio Global City, Taguig City, Philippines
(2014-04 - 2016-04)
- Managed regulatory dossier maintenance for post-approval activities, including variations and amendments, ensuring adherence to established submission timelines.
- Handled global eCTD and NeeS submissions, ensuring timely completion of all related tasks while maintaining regulatory compliance standards.
- Guaranteed adherence to submission publishing standards and conducted thorough quality reviews for reports such as PADER, PBRERs, PSURs, DSUR, and other ad-hoc reports.
- Leveraged technical expertise with publishing tools like Viewpoint, GDMS, Lorenz, EURS Validation, ISI Tool, ISI Publisher, eCTD Xpress, Aris G, SCEPTER, and Citrix Xen App to ensure regulatory compliance across multiple submission types.
- Collaborated effectively with team members to support submission workloads and managed the modification and assembly of complex reports for assigned products, adhering to quality standards.
- Maintained regulatory best practices and upheld Pfizer's compliance standards throughout the publishing process, contributing to the overall integrity of submissions.
Regulatory Affairs Lead/Head - DS Cosmeceutical Mfg Laboratory (Pharmaceutical & Cosmetic) - Santisimo Rosario, San Pablo, Laguna City, Philippines
(2002-08 - 2013-06)
- Oversaw all aspects of regulatory compliance, including CPR renewals, new drug applications, amendments, variations, and LTO renewals, along with pharmacovigilance reporting to ensure safety and regulatory adherence.
- Facilitated cross-functional collaboration with Production, QA/QC, and Packaging/Labeling teams to ensure comprehensive compliance with FDA regulations, enhancing process efficiency across departments.
- Provided strategic leadership by developing regulatory guidance and innovative strategies for submissions across multiple product categories, including drugs, food, cosmetics, and medical devices.
- Conducted quality assurance reviews of submission materials, marketing literature, and user manuals to uphold regulatory standards while retaining quality in communications.
- Streamlined processes by establishing regulatory priorities, managing budgets effectively, and allocating resources to enhance operational efficiency throughout regulatory functions.
- Led audits and coordinated preparations for FDA inspections, manufacturing plant audits, and product recalls, including preparation and submission of CAPA reports as necessary to mitigate issues quickly.
- Managed product complaints, monitored industry trends, and prepared regulatory submissions to address regulatory impacts swiftly and effectively.
- Trained and developed staff on regulatory policies and procedures, formulated SOPs, and optimized document publication systems for both hardcopy and electronic formats.
