Regulatory Affairs & Quality Compliance Supervisor

Join Pure Form as we build the future of wellness in Southeast Asia.

We've grown into the top supplement brand by making science-backed wellness more accessible through thoughtfully formulated products. Today, we're expanding across ASEAN with our regional headquarters in Singapore—bringing our vision to millions more.

But we're not just building a supplement company.

We're building a lifestyle brand that champions progress and holistic wellness. We believe the habits people practice every day shape the lives they live, and our mission is to help them supplement the good.

If you're excited by ambitious goals, high standards, rapid growth, and the opportunity to build an iconic consumer brand from Southeast Asia—for the world, we'd love to meet you.

Role Overview

We are seeking an experienced Regulatory Affairs & Quality Compliance Senior Specialist to bridge regional regulatory strategy and day-to-day quality execution in the Philippines.

You will lead Philippine FDA filings, regulatory intelligence, technical documentation, labeling and claims reviews, product compliance, quality incident response, and batch-release oversight. You will also translate regional requirements into practical local procedures, guide junior QA personnel, and support expansion across Southeast Asia.

This high-visibility role is suited to a compliance professional who can independently manage regulatory approvals, investigate product quality issues, and collaborate effectively with manufacturers, laboratories, warehouses, distributors, and internal teams.

Key Responsibilities

1. Regulatory Affairs, Intelligence, and Market Access

• Manage Philippine FDA filings, including License to Operate renewals, product registrations, amendments, and notification submissions.
• Serve as the primary technical representative during Philippine FDA audits, inspections, and official regulatory correspondence.
• Monitor Philippine regulatory developments, FDA advisories, enforcement trends, and changes affecting food supplements, labeling, advertising, importation, storage, and distribution.
• Assess regulatory changes and translate them into recommendations, internal procedures, compliance timelines, and business-impact updates.
• Monitor relevant regulatory developments across ASEAN markets and coordinate with local advisers or partners to identify regional registration and compliance requirements.
• Compile technical dossiers, stability reports, Free Sale Certificates, and other documents required for regional registrations, including Indonesia, Singapore, Malaysia, and Thailand.
• Support periodic regional travel for regulatory, supplier, warehouse, and quality-related activities.

2. Labeling, Claims, and Product Compliance

• Review product labels, packaging proofs, master artwork, ingredient lists, allergen declarations, and other product information for compliance.
• Evaluate website content, marketing materials, and promotional claims to ensure they are accurate, substantiated, and legally compliant.
• Maintain complete product compliance documentation covering the product lifecycle—from manufacturing and importation through warehousing and distribution.
• Coordinate the creation, completion, approval, and filing of compliance records with the appropriate internal and external teams.
• Support regulatory and non-regulatory product or business certifications, including Halal, Organic, Non-GMO, and other relevant standards.

3. Quality Systems and Batch Release

• Govern the Batch Release SOP and oversee its execution across technical review, brand and operations approval, and warehouse receiving checks.
• Review Certificates of Analysis and third-party laboratory reports covering potency, heavy metals, microbiological safety, and other required parameters.
• Verify that products meet approved specifications before recommending release for sale or distribution.
• Maintain accountability for product retention samples, including proper labeling, storage, inventory, traceability, and disposal.
• Oversee sample archiving and relevant quality or inventory records in systems such as Odoo and BigSeller.

4. Incident Response, Lockdowns, and CAPA

• Rapidly assess quality complaints, adverse findings, suspected contamination, counterfeit concerns, and other compliance alerts.
• Recommend product holds, inventory lockdowns, distribution suspensions, batch rejections, withdrawals, or recalls based on documented quality and compliance risks.
• Present supporting evidence and a clear risk assessment to authorized management for final decisions.
• Following management approval, coordinate the quarantine, identification, documentation, and control of affected inventory.
• Lead investigations into out-of-specification results, deviations, customer complaints, and non-conformance incidents.
• Collect supporting evidence such as warehouse temperature logs, storage photographs, cleanliness checklists, batch records, laboratory reports, and distribution data.
• Develop and monitor Corrective and Preventive Action plans with manufacturers, laboratories, suppliers, and internal teams.
• Maintain and oversee procedures for suspected counterfeit products, including reporting, documentation, product authentication, escalation, and coordination with relevant authorities or partners.
• Maintain complete records of recommendations, approvals, actions taken, and final incident outcomes.

5. Supplier and Manufacturer Compliance

• Review contract manufacturer documentation, including Batch Production Records, cGMP certificates, raw-material specifications, test reports, and manufacturing flowcharts.
• Help qualify suppliers and maintain the Approved Supplier List.
• Support supplier audits, certification reviews, quality investigations, and remediation activities.
• Ensure that required technical and compliance documents remain complete, current, and readily retrievable.

6. Warehouse and Distribution Compliance

• Conduct periodic quality and compliance reviews at warehouses and across relevant distribution channels.
• Verify appropriate storage, handling, sanitation, temperature control, stock rotation, and product traceability.
• Train warehouse, distribution, customer service, and sales teams on product handling, storage, complaint escalation, and quality procedures.
• Serve as a technical resource for product quality and compliance questions from commercial and operational teams.

7. Team and Cross-Functional Support

• Guide the QA Specialist in daily quality checks, retention-sample management, recordkeeping, and inventory-system updates.
• Collaborate with Product Development, Supply Chain, Marketing, Sales, Customer Service, and Operations on regulatory constraints and quality requirements.
• Provide clear technical recommendations that balance regulatory integrity, consumer safety, and commercial objectives.

Who You Are

• Bachelor's degree in Pharmacy, Chemistry, Food Technology, Food Science, or a related discipline.
• Registered Pharmacist licensure is strongly preferred, particularly where required for FDA filings or official representation.
• Five to eight years of progressive experience in regulatory affairs, product compliance, or quality assurance within supplements, pharmaceuticals, food manufacturing, or consumer health.
• Hands-on experience with Philippine FDA systems and processes, including LTO and product-registration submissions.
• Working knowledge of cGMP, HACCP, Good Storage Practices, quality systems, and product traceability.
• A plus if certified ISO, QMS
• Experience reviewing technical dossiers, product labels, laboratory reports, and manufacturing records.
• Demonstrated ability to investigate quality incidents, manage CAPAs, and prepare recommendations for product holds or lockdowns.
• Strong judgment, organization, attention to detail, and written and verbal communication skills.
• Ability to guide junior personnel and work effectively across technical and commercial teams.
• Proficiency in Microsoft Office and familiarity with ERP, PLM, quality, or inventory-management systems such as Odoo or BigSeller.
• Willingness to work on-site or in a hybrid arrangement, conduct periodic audits at the company's warehouse in Plaridel, Bulacan, and travel regionally when required.

WHAT YOU'LL LOVE ABOUT WORKING HERE

• Meaningful career growth: Gain exposure to regional regulatory strategy and hands-on quality operations.
• Regional impact: Help bring safe, compliant wellness products to markets across Southeast Asia.
• Professional influence: Apply your technical expertise and professional credentials in a fast-growing health and wellness company.
• Cross-functional collaboration: Work closely with leadership, product innovators, manufacturers, and supply-chain partners.
• A culture of progress: Join a team committed to Supplement Progress—supporting the growth of our people, products, and business.

MEASURES OF SUCCESS:

Performance will be evaluated based on:

• Timely submission, approval, and renewal of Philippine licenses and product registrations
• Accuracy and completeness of regulatory filings, technical dossiers, and compliance records
• Effective monitoring and communication of Philippine and relevant ASEAN regulatory developments
• Timely implementation of actions required by new or amended regulations
• Batch-release turnaround time and accuracy
• Timely investigation and closure of deviations, complaints, out-of-specification findings, and CAPAs
• Quality and timeliness of risk assessments and management recommendations
• Audit and inspection outcomes, including timely closure of findings
• Accuracy and completeness of retention-sample, supplier, warehouse, and product-compliance records
• Completion of required quality and compliance training
• Reduction in repeat quality incidents and documentation errors
• Effective coordination with manufacturers, laboratories, warehouses, distributors, and internal teams