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Pureform Technology

Regional Regulatory Affairs & Product Compliance Manager (Southeast Asia)

5-7 Years
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  • Posted 20 hours ago
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Job Description

Pure Form is a leading provider of high-quality food supplements dedicated to promoting health and wellness through clean formulations, honest science, and thoughtful design.

Our mission extends beyond physical health — we aim to build a company where people thrive as much as the brand does. We believe that when our team grows in purpose, creativity, and balance, the brand naturally flourishes.

ROLE OVERVIEW

This is an opportunity to build the regulatory foundation of a fast-growing consumer health company expanding across Southeast Asia. You'll influence product innovation before launch, shape market-entry strategy, and partner directly with leadership to accelerate growth while protecting the integrity of our brands.

We are looking for a dynamic Regional Regulatory Affairs & Product Compliance Manager (Southeast Asia) to lead our regional regulatory strategy, oversee product compliance, and drive certification initiatives across ASEAN. This is a commercial regulatory role—not a back-office compliance function. You'll help the business find the compliant path to market while protecting our right to sell and enabling sustainable growth.

Success looks like products launching on schedule, registrations remaining current, suppliers meeting regulatory standards, and new product development progressing without unexpected regulatory roadblocks.

You'll partner closely with Growth, Operations, NPD, Marketing, and external manufacturers, suppliers, testing laboratories, and regulatory consultants. You'll also lead our Quality Assurance Specialist, allowing you to focus on regional strategy, market expansion, supplier qualification, and high-impact regulatory decisions.

KEY RESPONSIBILITIES

1. Regulatory, Product Compliance and Market Access

  • Guide regulatory and licensing strategies across ASEAN markets for dietary supplements, health foods, and consumer products.
  • Lead regional product registrations, renewals, and market-entry activities while coordinating with internal teams and external regulatory partners.
  • Own the regional regulatory roadmap by identifying risks, opportunities, launch dependencies, and evolving regulatory requirements.
  • Advise business leaders during product development on formulation, ingredients, claims, and market-entry strategies before commercialization.
  • Determine product classifications, permissible ingredients, dosage limits, and marketing claims for each target market.
  • Build regulatory intelligence by monitoring legislative changes, competitor activity, and emerging industry trends.
  • Oversee complex regulatory submissions, while Regulatory Affairs Specialists manage routine Philippine FDA registrations and renewals.
  • Represent the company with regulatory authorities, responding to inquiries, deficiencies, and compliance matters.
  • Support import/export regulatory requirements and product clearance activities where applicable.
  • Provide realistic regulatory timelines that align commercial planning with market approval processes.

2. Product Certifications (Organic, Non-GMO, etc.)

  • Lead the end-to-end management of product certifications including Non-GMO Project Verified, USDA Organic, Halal, Kosher, and other relevant standards.
  • Coordinate certification bodies, documentation, audits, and ongoing compliance activities.
  • Evaluate certification opportunities that strengthen product credibility, consumer trust, and commercial competitiveness.

3. QA/QC Oversight

  • Develop and continuously improve scalable quality systems that support regional growth and operational excellence.
  • Review batch records, Certificates of Analysis (COAs), specifications, and technical documentation to ensure regulatory compliance.
  • Lead investigations into quality issues, consumer complaints, and CAPA implementation.
  • Monitor quality trends, audit findings, supplier performance, and customer feedback to drive continuous improvement.
  • Assess regulatory and quality impacts arising from formulation, packaging, manufacturing, supplier, or specification changes.
  • Partner with Operations and Supply Chain to strengthen preventive quality controls across the product lifecycle.

4. Supplier & Manufacturer Qualification

  • Lead regulatory and quality due diligence for suppliers and contract manufacturers, including GMP verification, technical documentation, and certification reviews.
  • Own supplier qualification, requalification, and the Approved Supplier List.
  • Review supplier quality agreements, technical documentation, and change notifications affecting regulatory compliance.
  • Support supplier audits and corrective action plans while monitoring supplier performance and continuous improvement.
  • Partner with Procurement and Operations to ensure supplier onboarding aligns with regulatory and quality standards.

5. Product Claims, Labeling & Packaging Support

  • Review product claims, labels, packaging, artwork, specifications, and consumer-facing materials to ensure regulatory compliance.
  • Approve final packaging artwork before commercialization.
  • Ensure all marketing campaigns, digital content, influencer communications, and advertising claims comply with applicable regulations.
  • Provide regulatory guidance on product positioning, naming, claims, and supporting scientific evidence.
  • Identify compliance risks and recommend practical, business-focused solutions.

6. Team Leadership & Cross-Functional Collaboration

  • Lead and develop the Regulatory Affairs and Quality Assurance teams by setting priorities, providing coaching, and building technical capability.
  • Manage external regulatory consultants, auditors, certification bodies, and contract partners across ASEAN markets.
  • Serve as the primary regulatory advisor to commercial, product, and executive leadership.
  • Represent Regulatory Affairs throughout product development and commercialization to balance regulatory integrity with business objectives.
  • Build regulatory awareness across the organisation through training, guidance, and best practices.
  • Promote a culture of quality, accountability, collaboration, and continuous improvement.

WHO YOU ARE

  • 5+ years of experience in Regulatory Affairs, Product Compliance, Quality Assurance, or a related function within consumer health, food, supplements, FMCG, or pharmaceuticals.
  • Strong knowledge of ASEAN regulatory frameworks, product registrations, labeling, and market access. Direct experience filing and maintaining registrations with the one or more ASEAN regulators (BPOM, PH FDA, HSA, NPRA,, VFA, Thai FDA) is a strong advantage.
  • Experience working with contract manufacturers, suppliers, testing laboratories, and certification bodies.
  • Experience managing product certifications such as Halal, Organic, and Non-GMO is advantageous.
  • Commercial mindset with the ability to balance regulatory integrity and business objectives.
  • Strong stakeholder management, communication, and influencing skills.
  • Excellent analytical, project management, and problem-solving capabilities.
  • Comfortable managing multiple regional priorities in a fast-paced environment.
  • Experience with regulatory documentation systems, ERP, PLM, or document management platforms is advantageous.
  • Proficient in Microsoft Office, particularly Excel and Word.
  • Flexibility to travel across Southeast Asia to support supplier qualification, regulatory engagement, audits, and key business initiatives.

WHAT YOU'LL LOVE ABOUT WORKING HERE

  • Competitive remuneration and comprehensive benefits.
  • Ownership of regional regulatory strategy with direct impact on product launches and market expansion.
  • The opportunity to partner closely with founders and executive leadership on strategic growth initiatives.
  • A chance to build regulatory capabilities that influence how innovative wellness products reach millions of consumers across Southeast Asia.
  • Join a high-performing team that values ownership, speed, collaboration, and continuous improvement.

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About Company

Job ID: 151071405