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APAC Regulatory Compliance Head

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A leading FMCG and a purpose-driven conglomerate operating in over 80 countries.

职位描述

We are seeking a detail-oriented Regulatory Compliance Specialist to ensure our products and operations adhere to relevant local and international regulations. The successful candidate will play a critical role in managing regulatory registrations, maintaining compliance documentation, and supporting cross-functional teams to mitigate legal and regulatory risks. This role requires strong knowledge of industry-specific regulations and excellent communication skills to collaborate with internal stakeholders and regulatory authorities. Key Responsibilities Regulatory Registration Management Lead the registration process for products with regulatory agencies (e.g., FDA, EMA, NMPA), including preparing and submitting dossiers, responses to inquiries, and post-market updates. Monitor regulatory changes and ensure timely adaptation of registration strategies to comply with new requirements. Compliance Documentation & Maintenance Develop, review, and maintain regulatory files (e.g., technical documentation, labeling, safety reports) to ensure accuracy and compliance with global standards (e.g., GMP, ISO). Manage the lifecycle of compliance records, including archiving, version control, and internal audit support. Regulatory Monitoring & Risk Mitigation Track and analyze regulatory updates across target markets, providing actionable insights to internal teams (R&D, Quality, Marketing) to prevent non-compliance. Collaborate with legal and quality assurance teams to address regulatory violations or complaints, developing corrective action plans as needed. Cross-Functional Collaboration Liaise with product development teams to ensure new products align with regulatory requirements from concept to launch. Coordinate with external partners (e.g., consultants, testing labs) to facilitate regulatory submissions and audits. Training & Guidance Conduct internal training sessions on regulatory compliance best practices and emerging regulations. Serve as a subject matter expert, providing guidance to stakeholders on regulatory requirements and processes.

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