Location | : | Bangkok, Thailand |
Job type | : | Permanent |
Salary | : | 100-150k |
Regulatory Affairs Manager/Senior Regulatory Affairs Specialist II Company Overview: Our client is a multinational provider of hygiene, water treatment, and infection prevention solutions, serving a broad range of industries including food production, healthcare, manufacturing, hospitality, and institutional services. Operating across more than 150 countries, it supports clients in maintaining safe, efficient, and sustainable operations. The company offers a wide portfolio of technologies and services that help optimize resource use, ensure regulatory compliance, and promote high standards in sanitation, public health, and environmental management. Its solutions are used in mission-critical settings to ensure clean water, food safety, and operational resilience. With a strong emphasis on science-based innovation, sustainability, and global service capabilities, the organization is recognized as a trusted partner for businesses aiming to improve performance while reducing their environmental impact. Role Summary: They are seeking a highly experienced Senior Regulatory Affairs professional to lead and support regulatory strategies across the full product lifecycle — from development to post-market compliance. The ideal candidate is a commercially-minded, detail-oriented, and cross-functionally collaborative leader who understands the critical role of regulatory compliance in driving business success. This role offers the opportunity to shape and execute regulatory strategies across local and international markets, liaise with health authorities, and serve as a key partner to R&D, QA, Legal, and business leadership. Key Responsibilities: Strategic Leadership & Compliance ExecutionDevelop and implement regulatory strategies that ensure compliance with relevant laws, guidelines, and industry standards.Stay current on changes in global and local regulatory requirements and translate updates into actionable internal processes.Lead regulatory activities for product registrations, pre-market submissions, post-market surveillance, and lifecycle management.Cross-Functional & Business CollaborationPartner closely with cross-functional teams including R&D, Quality Assurance, Legal, and Commercial to integrate regulatory considerations early and effectively.Act as a regulatory advisor during innovation or change processes, ensuring speed-to-market while maintaining compliance.Participate in cross-functional meetings to align regulatory input with business goals.Health Authority Engagement & DocumentationPrepare and manage regulatory submissions and act as the primary liaison during audits, inspections, and official agency communications.Review and approve product labels, promotional materials, and technical documents for regulatory accuracy.Lead or support risk assessments and mitigation plans for regulatory-related issues.Monitoring & Global Expansion SupportTrack regulatory compliance metrics and report updates to leadership regularly.Maintain understanding of global regulations (e.g., FDA, EU MDR, ASEAN, ISO) and advise on international expansion from a regulatory standpoint.Qualifications & ExperienceBachelor’s degree in a scientific, engineering, or related technical discipline (Master’s degree preferred).8–10 years of progressive regulatory affairs experience in a regulated industry (e.g., healthcare, life sciences, medical devices, food).Proven success in managing regulatory submissions and securing product approvals.In-depth knowledge of applicable global regulatory frameworks (e.g., FDA, EU regulations, ISO standards).Hands-on experience with audits, inspections, and regulatory authority interactions.Strong business acumen and the ability to align regulatory actions with commercial goals.High attention to detail with the ability to interpret and assess complex technical and scientific documents.Excellent written and verbal communication skills, adaptable to both technical and non-technical audiences.Strong project management capabilities; able to manage multiple priorities under tight timelines.Proficient in regulatory systems and tools for tracking and submission management.Collaborative team player with the ability to influence cross-functional stakeholders.Analytical thinker and proactive problem-solver.