Regulatory Affairs Manager

Regulatory Affairs Manager is responsible for ensuring that all products comply with local and international regulations, including product registration, labeling, and packaging requirements. It plays a key role in the successful launch of new products by managing all regulatory aspects, from development to commercialisation.

Responsibilities

• Responsible for product registration, renewal, post approval changes and advertising approval by Thai FDA in compliance with Thai FDA regulations
• Meet marketing objectives and timeline of the launch plan for new products
• Communicate the approved information and/or any change to the departments concerned within/outside company
• Take initiative in local Government Affairs activities by cultivating close relationships with government agencies to influence and respond proactively to the development of laws and regulations that are governing product registration.
• Provide input and advance warning on potential regulatory and quality risks and propose/develop preventive and corrective strategies.
• Maintain a high level of Regulatory intelligence; keep informing on existing and developing regulations, guidelines, laws and overall competitive landscape.
• Manage and coordinate all activities for the products according to Thai FDA regulations
• Supervise RA team and responsible for regulatory tasks

Required Business Experience / Skills / Qualifications

• Bachelor's or Master's degree in Cosmetic Science, Pharmacy, or a related field (preferred).
• Strong background and hands-on experience in Regulatory Affairs, Product Licensing, and Claims Management for Beauty, Skin Care, Personal Care, or Luxury Retail products.
• Minimum 5 years of managerial experience, preferably within an international or complex organizational environment.
• Excellent attention to detail, strong organizational skills, and the ability to manage multiple priorities.
• Highly responsible, proactive, energetic, and self-driven, with a positive attitude and strong initiative.
• Established and positive relationships with Thai FDA officers.
• Strong analytical ability to evaluate regulatory situations, assess risks, and provide sound recommendations or decisions.
• Proven leadership skills with the ability to manage and develop teams, set priorities, and collaborate effectively across functions to build a strong culture and team capability.
• Strong command of English and Thai (reading, writing, and speaking), with the ability to communicate effectively with internal and external stakeholders.
• Proficient in MS Office and general computer literacy.