Regulatory Pharmacist

Carabao Commercial Corporation; Metro Manila; On-site; PHP 700,000 - 950,000; Full time

Benefits offered by this job

On-site role in Metro Manila

Job summary

Carabao Commercial Corporation is seeking a Regulatory Pharmacist to ensure compliance with Philippine regulatory requirements for pharmaceutical, food, cosmetic, and related products. The role covers registrations, licenses, labeling reviews, and cross-functional regulatory guidance.

The successful candidate will coordinate with FDA and government agencies, manage regulatory documents, and support audits, inspections, and pharmacovigilance activities.

Qualifications

• Licensed Pharmacist in the Philippines with regulatory affairs experience.
• Strong knowledge of FDA/philippines regulatory requirements.
• Detail-oriented with ability to manage multiple submissions and deadlines.

Responsibilities

• Prepare, review, and submit regulatory documents for health, cosmetic and related products.
• Monitor regulatory requirements and maintain product dossiers and licenses.
• Coordinate with FDA, distributors, principals, and internal teams.
• Review product labels and marketing materials for regulatory accuracy.
• Support pharmacovigilance and handle regulatory communications.
• Maintain regulatory records and support audits and inspections.
• Provide regulatory guidance to cross-functional teams and assist trainings.

Skills

Regulatory affairs

Pharmacy knowledge

Regulatory compliance

Communication skills

Attention to detail

Project coordination

Education

Licensed Pharmacist in the Philippines

Pharmacist degree / Pharmacy degree

Tools

Regulatory information systems

Office software

Job description

Carabao Commercial Corporation is seeking a detail-oriented and highly organized Regulatory Pharmacist to support the company’s compliance with Philippine government regulations governing the importation, distribution, registration, and sale of pharmaceutical, food, cosmetic, and related products.

The Regulatory Pharmacist will serve as the company’s designated pharmacist and will manage regulatory documentation, product registrations, government licenses, compliance monitoring, pharmacovigilance coordination, and regulatory communications with government agencies, principals, distributors, and other business partners.

This role will work closely with the Regulatory Head, Management, marketing, product management, warehouse, logistics, quality, ethics, and commercial teams to ensure that all products and business activities comply with applicable regulatory requirements..

Role Description

The Regulatory Affairs Pharmacist is responsible for preparing, reviewing, and submitting regulatory documents and applications for health and wellness, pharmaceutical, and related products, ensuring compliance with Philippine and international regulatory standards. The role involves monitoring updates to regulatory requirements, maintaining product registration dossiers, and coordinating with government agencies, suppliers, and internal teams to secure approvals and renewals within required timelines. The pharmacist will review product labels and marketing materials for regulatory accuracy, support quality and safety evaluations, and assist in developing internal policies aligned with current regulations. Daily activities also include maintaining organized regulatory records, supporting audits and inspections, and providing regulatory guidance to cross-functional stakeholders.

Specifically, he/she shall be responsible for the following:

1. Regulatory Licensing and Registration

Serve as the company Pharmacist of Carabao Commercial Co. and handle the company’s regulatory requirements and applications with the Food and Drug Administration (FDA), and all its departments including but not limited to Manage the company’s License to Operate applications, renewals, variations, and related requirements.

Prepare, review, and submit applications for product registration, licensing, renewals, amendments, variations, and other regulatory requirements for: pharmaceutical products, cosmetics, food products, and other related products

Ensure that Certificates of Product Registration, Licenses to Operate, and other regulatory documents remain valid, complete, and properly updated.

Assist the regulatory team and officers with other government registrations and regulatory activities.

2. FDA Applications and Compliance

Prepare complete and accurate regulatory submissions in accordance with current FDA guidelines and applicable Philippine regulations.

Monitor applications from initial submission through approval and issuance of the relevant licenses or certificates.

Regularly follow up on pending applications and coordinate with the FDA regarding application status, deficiencies, clarifications, and timelines.

Prepare and submit responses to deficiencies, amendments, variations, renewals, and other regulatory correspondence.

Coordinate with distributors and business partners during the processing of product applications, including CLIDP-related submissions.

Communicate with principals and manufacturers regarding product registration, regulatory compliance, product concerns, and required clarifications.

Represent the company during FDA inspections, audits, and regulatory meetings.

3. Product Label and Promotional Material Review

Review primary and secondary product labels for initial registration, CLIDP applications, renewals, amendments, and variations.

Verify that labels, packaging, technical materials, and product information comply with applicable FDA labeling requirements.

Proofread labels, formulations, technical documents, product information, and other regulatory materials for accuracy, consistency, and completeness.

Provide regulatory guidance to marketing, product management, and commercial teams. He/she reviews product claims and coordinates with the internal team regarding substantiation of claims used in social media content, marketing materials, product brochures, merchandise, events, and other promotional activities.

4. Pharmacovigilance and Product-Related Concerns

Support compliance with pharmacovigilance requirements of the FDA and global partners.

Monitor, document, and coordinate the handling of product complaints, adverse events, and other product safety concerns and facilitate corrective actions within the company’s scope of operations.

Maintain and manage product retention samples for incoming shipments in coordination with the warehouse and logistics teams.

5. Documentation and Regulatory Records

Maintain an updated master list of all registered products, CPRs, LTOs, licenses, permits, and regulatory applications and prepare and monitor renewals of Certificates of Product Registration and other time-sensitive regulatory submissions.

Ensure proper storage and accessibility of authenticated documents, certificates, permits, product dossiers, inspection records, and regulatory correspondence.

Maintain documentation of submissions, approvals, deficiencies, amendments, variations, renewals, and regulatory commitments.

Ensure that the company’s Standard Operating Procedures are updated and aligned with current FDA regulations and conduct internal compliance checks and audits to identify regulatory gaps and recommend corrective actions.

Conduct periodic reviews of regulatory procedures and documentation to support audits and compliance activities.

6. Cross-Functional and Field Support

Provide regulatory advice and support to internal departments and external partners.

Collaborate with marketing, product management, quality, ethics, warehouse, logistics, sales, and commercial teams.

Write or review technical and health-related content for the company newsletter, website, and other communication platforms.

Assist with product training, launches, exhibitions, and Brand Partner events.

Travel to other cities and provinces, including occasional weekends or evenings, when required for company activities, inspections, and events.

Perform other regulatory and compliance-related duties assigned by the Regulatory Head or Management.

Qualifications

• Strong foundation in Pharmacy and Regulatory Affairs, with the ability to apply professional pharmaceutical knowledge to regulatory processes.
• Demonstrated understanding of Regulatory Compliance and Regulatory Requirements relevant to pharmaceuticals, health products, and imported goods.
• Effective Communication skills, including clear written documentation, stakeholder coordination, and the ability to present regulatory findings and recommendations.
• Licensed Pharmacist in the Philippines, with experience in regulatory affairs, quality assurance, or related fields preferred.
• Familiarity with Philippine FDA regulations and other applicable local and international regulatory agencies.
• High attention to detail, strong organizational skills, and the ability to manage multiple submissions and deadlines.
• Proficiency with standard office software and document management tools; experience with regulatory information systems is an advantage.
• Ability to work on-site in Quezon City, collaborate within cross-functional teams, and uphold ethical and professional standards.