Regulatory Affairs Specialist

Responsibilities:

• Ensure all health supplement products comply with applicable regulations in target markets (e.g., US FDA, EU EFSA, ASEAN, China NMPA, Australia TGA, and other relevant authorities).
• Prepare, review, and submit regulatory dossiers, product registrations, notifications, and renewals as required by each jurisdiction.
• Interpret and apply evolving international regulations related to health supplements, nutraceuticals, and functional foods.
• Build and maintain direct relationships with regulatory authorities and government agencies in each target country, proactively engaging to facilitate smoother and faster product registration processes.
• Develop country-specific regulatory strategies and submission timelines, leveraging established relationships with local regulatory contacts to reduce registration lead times.
• Act as the primary point of contact for in-country regulatory agents, distributors, and local consultants, coordinating closely to resolve queries, track submission status, and accelerate approvals.
• Review and approve all labeling, claims, and marketing materials for regulatory compliance.
• Maintain and update a global regulatory intelligence database to proactively track legislative changes.
• Advise internal stakeholders on regulatory risks and develop mitigation strategies for new market entries.
• Lead regulatory due diligence activities for new product development, acquisitions, or partnerships.

Qualifications:

• Bachelor's degree required in Life Sciences, Pharmacy, Food Science, Biochemistry, Nutrition, or a related field. Master's degree or MBA is preferred, particularly with a focus on regulatory affairs, product management, or international business.
• 3+ years of experience in regulatory affairs within the health supplement, nutraceutical, pharmaceutical, or functional food industry.
• Exposure to e-commerce and digital health supplement channels. Prior experience in a multinational or regional FMCG/healthcare company. Experience in markets such as Southeast Asia, China, Middle East, or USA is a strong advantage.
• Demonstrated experience managing product registrations and regulatory submissions across multiple international markets.
• Track record of successfully launching health supplement products from concept to market.
• Experience working with contract manufacturers (CMOs) and managing complex cross-functional projects.
• Strong knowledge of global health supplement regulations (FDA DSHEA, EU Food Supplement Directive, CODEX Alimentarius, GMP standards, etc.).
• Proficiency in regulatory submission platforms and document management systems.
• Understanding of ingredient safety assessments, clinical substantiation, and health claim regulations.
• Familiarity with GMP, ISO, and quality assurance standards applicable to dietary supplements.
• Excellent project management skills with the ability to manage multiple priorities in a fast-paced, international environment.
• Strong analytical and critical thinking skills; ability to interpret complex regulations and translate them into actionable business guidance.
• Outstanding written and verbal communication skills in English; proficiency in additional languages is a strong advantage.
• Highly collaborative with strong stakeholder management capabilities across cultures and time zones.
• Entrepreneurial mindset with a bias for action and a commitment to quality.