Regulatory Affairs Manager

Regulatory Compliance

• Oversee end-to-end regulatory activities and processes with a primary focus on Thailand ensuring compliance from product development production/importation to commercialization.
• Act as the regulatory representative for Laos Cambodia and Myanmar working closely with local distributors and their regulatory teams to ensure compliance with local requirements.
• Monitor and interpret local regulations for cosmetics and/or medical devices and assess impact on business operations.
• Act as the key contact with Thailand FDA and relevant authorities and collaborate with distributors for regulatory matters in CLM markets.
• Identify regulatory risks and provide practical mitigation plans to support business continuity. Local Regulatory Activities

Regulatory Operations

• Be accountable for timely and accurate product notification/registration in Thailand ensuring completeness and quality of submissions prepared by the team; oversee submission progress in CLM markets via distributors.
• Provide guidance on product classification naming and regulatory requirements across all responsible markets.
• Be accountable for right-first time and on-time artwork and labeling approval ensuring completeness and compliance of outputs prepared by the team.
• Assess product claims and supporting documents and advise Marketing/R&D on compliance requirements and support needed.
• Provide clear regulatory guidance on the product claim and concepts in the local language ensuring regulatory compliance while supporting business objectives.
• Coordinate with external parties (e.g. testing labs) for claim substantiation where required.
• Review and approve advertising materials (digital TVC website) in line with Thailand regulations ensuring compliance and alignment with internal standards.
• Liaise including preparing supporting document and defend with relevant authorities (Thailand) for advertising approvals or claim justifications when required.
• Ensure completeness and maintenance of Product Information File (PIF) for Thailand
• Provide regulatory training to internal stakeholders and where applicable support knowledge sharing with distributors to enhance compliance awareness.
• Identify and challenge non-compliant competitor claims and represent the company in defending product claims with regulatory authorities as needed.

Leadership & Team Development

• Lead and manage the regulatory team ensuring high performance and strong engagement.
• Coach and develop team members to enhance regulatory knowledge and capabilities.
• Drive continuous improvement in regulatory processes and ways of working.

• Bachelors degree in science Chemistry or a related field preferably in Pharmaceutical Sciences
• Minimum of 5 years of experience in Regulatory Affairs preferably within the cosmetics industry in a multinational environment
• Strong analytical & problem-solving skills with the ability to assess regulatory risks and propose practical solutions
• Good commercial awareness with the ability to balance compliance requirements and business objectives
• Excellent communication and stakeholder management skills with the ability to influence and negotiate effectively
• Strong logical thinking and decision-making ability
• Fluent in English (both written and spoken)
• Competences in Leadership capabilities with strong teamwork and resilience in a fast-paced