Head of Regulatory Affairs, APAC COE

Job Details

• Job Title: Head of Regulatory Affairs, APAC CoE
• Location: Bangkok, Thailand/ Shah Alam, Malaysia
• Work Arrangement: Hybrid

About the Role

The Head of Regulatory Affairs, APAC COE is responsible for establishing and driving regulatory excellence across the APAC region. This role provides strategic leadership, governance, performance management, and continuous improvement initiatives to ensure compliance with applicable regulations governing products, imports, exports, licenses, permits, and supply chain activities.

The role partners closely with Commercial, Supply Chain, Procurement, Quality, HSE, Manufacturing, Customer Service, Logistics, and Legal teams to ensure regulatory compliance while supporting business growth objectives across all APAC entities.

As a regional Center of Excellence (COE) function, the role will define regulatory standards, governance frameworks, compliance monitoring processes, and capability-building programs for the region.

Key Responsibilities

Regulatory Affairs Excellence

• Define and implement APAC Regulatory Affairs strategy and operating model.
• Establish regional regulatory governance, policies, SOPs, and compliance frameworks.
• Drive a proactive regulatory compliance culture across APAC businesses.
• Ensure consistency of regulatory processes and standards across countries.

Product Registration & Compliance

• Provide governance and oversight for product registrations, renewals, and regulatory submissions.
• Develop standardized processes for product approval and maintenance activities.
• Ensure products comply with country-specific regulatory requirements.
• Monitor regulatory status and identify risks impacting business continuity.

Trade Compliance & Licensing

• Lead regional governance for import/export compliance activities.
• Oversee permits, licenses, and regulatory approvals required for business operations.
• Support compliance with customs, hazardous goods, chemical regulations, and trade requirements.
• Coordinate regulatory risk assessments related to cross-border transactions.

Regulatory Intelligence & Risk Management

• Monitor emerging regulatory changes affecting APAC businesses.
• Assess business impact arising from regulatory developments.
• Provide guidance to stakeholders on regulatory implications and compliance requirements.
• Lead escalation and mitigation plans for critical regulatory risks.

KPI & Performance Management

Own and monitor Regional Regulatory Affairs KPIs including

Product Registration Completion Rate

Registration Lead Time

Permit & License Renewal Compliance

Regulatory Audit Findings

Regulatory Incident Management

Compliance Rate

Product Approval Cycle Time

Corrective Action Closure Rate

Continuous Improvement

• Lead regulatory process improvement and harmonization initiatives.
• Standardize best practices across APAC countries.
• Drive digitalization and automation opportunities within regulatory processes.
• Support ERP, compliance management, document management, and business transformation initiatives.

Capability Building

• Establish Regulatory Affairs competency framework across APAC.
• Conduct regional regulatory training and awareness programs.
• Support development of local regulatory teams.
• Develop knowledge-sharing platforms and communities of practice.

Skills

Skills & Competencies

Product Registration & Product Stewardship

• Chemical Regulations and Hazard Communication
• Food and Pharmaceutical Regulatory Requirements
• Trade Compliance and Customs Regulations
• Import and Export Licensing
• Dangerous Goods Classification and Transportation Requirements

Safety Data Sheet (SDS) Governance

Product Labeling and Packaging Compliance

Regulatory Risk Assessment

• Regulatory Intelligence and Change Management
• ESG, Sustainability, and Environmental Compliance Requirements
• Regulatory Documentation and Audit Readiness

Job Requirements

Education

Bachelor's Degree in Regulatory Affairs, Chemistry, Food Science, Pharmaceutical Science, Life Sciences, Chemical Engineering, Supply Chain, or related discipline.

Master's Degree preferred.

Experience

• Minimum 10 years of progressive experience in Regulatory Affairs, Product Compliance, Trade Compliance, Product Stewardship, Quality, or related functions.
• Minimum 5 years in a leadership role with regional or multi-country responsibilities.
• Proven experience managing regulatory requirements across multiple APAC countries.
• Experience within the Specialty Chemicals, Life Sciences, Food Ingredients, Pharmaceuticals, Personal Care, Industrial Chemicals, or Distribution industries preferred.
• Strong knowledge of local and international regulatory frameworks, import/export regulations, product registration requirements, and compliance governance.
• Experience engaging with government agencies, regulatory authorities, customs bodies, and industry associations.
• Demonstrated success in leading compliance programs, audits, risk mitigation initiatives, and regulatory transformation projects.

About Caldic

At Caldic, we’re a global leader in distribution solutions, serving diverse markets across the world. Joining us means becoming part of an entrepreneurial, collaborative, and innovation-driven team.

We offer

Global opportunities with rapid career growth and development

An inclusive, diverse, and dynamic work environment

The chance to shape the future of specialty ingredient solutions across industries like food, pharma, personal care, and more

We operate in 43 countries around the world. Our innovative solutions are tailored to meet the needs of industries such as food, pharma, personal care, and industrial markets, ensuring sustainable success for all stakeholders. To learn more, visit: www.caldic.com

Ready to Join Us?

If you're ready to take your career to the next level and join a global leader, apply now at Caldic!

Equal Opportunity Employer

Caldic celebrates diversity and is committed to fostering an inclusive work environment. We do not discriminate on the basis of race, religion, gender, or any other characteristic.